CHAPTER 5
ADMINISTRATIVE ACTIONS
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CONTENTS
SUBCHAPTER - CITATIONS
Purpose.............................................131
Legal Authority.....................................131
Citation Under Multiple Laws........................131
Criteria for Citation...............................132
Determining the Need for Citation...................132
Time Frames.........................................132
Field Office Citation Procedure.....................133
Drug Advertising Citations..........................136
Exhibits............................................136
SUBCHAPTER - DETENTIONS
Background..........................................136
Authority...........................................137
Program Policy......................................137
Criteria for Effecting and Terminating Detentions...137
Procedures..........................................138
SUBCHAPTER - ADMINISTRATIVE DETENTIONS OF DEVICES
Purpose.............................................138
Detention of Devices................................138
Appeal of a Detention Order.........................141
Informal Hearing on Appeal of a Detention Order.....143
Requirements After a
Hearing On Appeal of a Detention Order...144
Exhibits............................................145
SUBCHAPTER - LICENSE REVOCATION OR SUSPENSION
Purpose.............................................145
General.............................................146
General Considerations, Revocation..................146
General Considerations, Suspension..................146
Procedure/Guidance, Revocation......................146
Procedure/Guidance, Suspension......................146
SUBCHAPTER - SECTION 305 MEETING
Purpose.............................................148
Authority...........................................148
Preparation.........................................148
Attitude of Compliance Officer......................148
Respondents' Request for Special Information........149
Conducting the 305 Meeting..........................149
Procedures after Meeting............................153
Exhibits............................................153
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SUBCHAPTER
CITATIONS
PURPOSE
This subchapter establishes the Food and Drug Administration's procedures
for the issuance of Section 305 Notices.
LEGAL AUTHORITY
Section 305 Notices are issued pursuant to Section 305 of the Federal
Food, Drug, and Cosmetic Act, which states:
"Before any violation of this Act is reported by the Secretary
to any United States attorney for institution of a criminal proceeding,
the person against whom such proceeding is contemplated shall be given
appropriate notice and an opportunity to present his views, either orally
or in writing, with regard to such contemplated proceeding."
NOTE: Citation may be utilized ONLY when a prosecution recommendation
is definitely being considered by the agency. Citation should not be used
for warning purposes.
CITATION UNDER MULTIPLE LAWS
On occasion, the same or related conduct that violates the Food, Drug,
and Cosmetic Act may also constitute a violation of one or more other federal
laws, including the licensing provisions for biologics of the Public Health
Service Act (42 U.S.C. 262), the False Reports to the Government Act (18
U.S.C. 1001) and conspiracy.
In such a case, identify the section of each law under which action
is contemplated, and the specific actions considered to violate that law.
CRITERIA FOR CITATION
The basic criteria for consideration of citation are as follows:
1. A violation of the law has been established and the agency has evidence
in its possession to support the case in court.
2. The violation is significant in terms of consumer protection.
3. Except in cases involving a health hazard, fraud, or extremely gross
violations, prior warning must have been given to the firm and each individual
involved. This prior warning may be in the form of conferences, previous
meetings, letters or discussions of Form FD 483 at the conclusion of inspections
or previous court actions. In instances where the prior warning was in
the form of letters or Section 305 Notice involving past violations, copies
must have been directed to each individual to be cited. NOTE: additional,
more specific criteria in many areas may be found in the Compliance Policy
Guides and Compliance Program Guidance Manual.
DETERMINING THE NEED FOR CITATION
The District Compliance Branch has the responsibility to decide whether
citation is warranted. The compliance officer to whom the case is assigned
should carefully check to determine whether there are other samples to
be considered. This search for other samples may include the following:
1. Obtaining a "printout" on the firm from the Data Processing
Unit.
2. Checking with the laboratory to determine if there are other samples
identified with the firm in process.
3. Checking the collection report on the sample initially considered
to make certain that all related samples are attached.
4. Checking outstanding sample assignments.
If there are other pending samples or an establishment inspection report
which has not been completed and no seizure is contemplated using any of
the samples involved, you may wish to defer action until the entire case
can be considered at one time. In such instances, the matter should be
discussed with Investigations and/or Laboratory Branch to expedite processing
of the report or additional samples.
When the package is complete, the reviewing officer should study the
firm's regulatory history and determine who was responsible for the violations
and whether prior warning had been given. In labeling violations, the file
would be searched to ascertain whether the labeling has been revised since
the shipment of the samples under question. Inspection reports must be
reviewed to assure that the inspectional observations coincide with the
adulteration found in the product. Availability of reserve samples should
also be determined.
Citation may issue on the basis of establishment inspection evidence
only. A minimum of two documentary samples covering violative products
should be obtained.
NOTE: Under normal circumstances, an opportunity for presentation of
views will always be given before the violations are reported for criminal
prosecution. However, there are certain circumstances under which no opportunity
will be given. Principal among these is where there is evidence of a continuing
conspiracy to violate federal law and evidence may be destroyed if the
conspirators are alerted by a Section 305 Notice. Another situation in
which no opportunity may be given is when there is a strong suspicion that
the proposed defendants will flee if alerted. See 21 CFR 7.84(a)(2).
Such situations are infrequently encountered and should be approved
on a case by case basis. Submit the facts to the center and request concurrence
from the center, OE, and GC when you do not believe providing an opportunity
for presentation of views would be appropriate.
TIME FRAMES
The following time frames (working days) apply to citations:
Field
15 days after collection of most recent sample involved in case.
Center
15 days after receipt.
There may be good reasons why time frames in a particular case are not
met; as examples, many analyses are time consuming and establishing responsibility
may require the assistance of other districts. Documents in the case file
should reflect the cause of delays.
FIELD OFFICE CITATION PROCEDURES
AUTHORIZATION TO CITE
Citation may issue either on a direct basis or after the submission
of a recommendation to the appropriate center and receipt of concurrence
to issue the section 305 Notice.
In routine cases, it is incumbent upon the office issuing the Section
305 Notice to assure that the firm and each individual to be cited has
received prior warning, unless such warning is not required.
Direct Citation
The Compliance Policy Guides Manual gives blanket authority to field
offices to issue Section 305 Notices in cases where specific criteria are
met. Most of these guidelines involve filth violations or noncompliance
with standards. This manual should be routinely checked each time the district
office believes citation is the action of choice to preclude the submission
of unnecessary recommendations to a center.
Citation Recommendation
In the case of violations where the district office does not have direct
citation authority, a citation recommendation must ordinarily be submitted
to the appropriate center for approval. That recommendation may take on
one of two forms, depending on whether the case is considered by the district
office to be "routine" or "non-routine."
Routine
Submit a "brief summary" of the facts to the appropriate center
in support of the request for citation authority. The summary should include
a brief statement of the background, the situation and facts supporting
prosecution consideration, identification of the individuals and firm to
be charged, and charges to be used.
If a prosecution is subsequently submitted, it will be submitted to
the Center in complete detail for review.
Non-Routine
Submit a detailed recommendation to the appropriate center for review.
The submission should include the full background, history of notification,
and the facts supporting the violation for prosecution consideration. The
names and responsibilities of each individual to be cited, as well as the
charges to be used and the samples to be used must be included. Labels,
work-sheets, and pertinent inspection reports should also be submitted.
Interstate documentation remains the responsibility of the districts, and
need not be submitted. The center, however, may request the IS documentation
if a special need to review it exists.
If a prosecution is subsequently submitted, the full details contained
in the citation recommendation need not be repeated. It would be sufficient
to refer to the citation recommendation. The prosecution recommendation
would, of course, still contain the information necessary to process the
case. What would not be repeated would be the full background, history
of warning, etc.
In both of the above situations any significant changes in the information,
resulting either form the 305 meeting of from other sources, must be brought
to the attention of the center at the time the prosecution is submitted.
If the information is such that a prosecution will no longer be considered,
the center should be advised of that fact.
Citation Recommendation After or
Concurrently with Seizure
When a seizure action has been forwarded to the administration and the
district later decides that citation is warranted, a memorandum containing
the necessary references to enable the center to tie in the citation recommendation
with the previous seizure should be submitted. Make sure that labeling
and other documents needed by the center to give proper consideration to
the case, are in its possession.
When the district office is considering prosecution at the same time
it is recommending seizure, a recommendation flagged "Seizure and
Citation Recommendation" should be submitted.
DETERMINATION OF CITEES
Corporations, Partnerships, and Associations
Corporations, partnerships, and associations are "persons"
under the Act, and may be prosecuted as separate legal entities, and should
always be included in the citation.
Individuals
The question of citing individuals is a most important one which calls
for careful consideration in every case. Bear in mind that prior warning
is a prerequisite in all but danger to health, fraud, and gross violations.
It is FDA policy to cite officers of corporations and members of partnerships
and associations, when the available evidence establishes that the individual
stood in a "responsible relationship" to the violation. As stated
in U.S. v. Park:
"The Act imposes not only a positive duty to seek out and remedy
violations when they occur but also, and primarily, a duty to implement
measures that will insure that violations will not occur."
Persons who have the power and authority, and therefore the responsibility,
to carry out the duties stated by the Supreme Court, and fail to do so,
are logical candidates for citation.
The type of information needed to demonstrate responsibility can be
obtained from observations reported by the investigators or through correspondence
and/or memoranda of conferences with the individuals or through other means.
Information may need to be obtained from officers located at a parent plant
in another state, as well as persons at the inspected plant.
SETTING DATE FOR MEETING
If the firm and individuals to be cited are located either in the same
city as the office in which the meeting is to be held of within reasonable
proximity, the meeting should be scheduled for approximately 10 days after
the issuance of the Section 305 Notice. If the citees will be required
to travel extensive distances or corporate citee will, in all probability,
wish to have a corporate attorney in attendance, or the violations involved
are complex, schedule the meeting approximately 20 days after the issuance
of the Section 305 Notice.
If more than one person is named in a Section 305 Notice, a separate
meeting for any named person shall be scheduled on request. This may be
a separate time on the same date, or on a separate date. Requests should
be addressed to the office that issues the Section 305 Notice, and must
be received at least three working days before the meeting is scheduled.
Requests for separate meetings should be in writing.
PREPARATION OF CITATION DOCUMENTS
Section 305 Notice (Exhibit 5-1)
Insert district address under the printed heading "Food and Drug
Administration." Under the caption at the right, "In reply refer
to," insert the key or file reference sample number for the action,
and "et. al." if there are several samples involved.
If there is only one product or class of products, such as "drugs,"
bakery products," etc., it may be inserted directly below the reference
sample number. The complete list of samples will appear on the Charge Sheet
along with the respective products. Enter the date Notice is issuing directly
above the rectangle on "Section 305 Notice" or centered under
the city and state of the district's address.
In the space for addressee, insert the name and address of the firm
or sole owner who is being cited (primary citee). When the citation also
names responsibility individuals, address in the following manner:
Standard Pharmaceutical Co.
and Mr. Henry Jones
and Mr. John Doe
125 Main Street, Canton, Ohio 28531
(Do not show titles of individuals listed as citees.)
In the body of the Notice, following the phrase "with respect to
the following," enter clear, concise statements identifying the specific
interstate shipment and product for each sample on which citation is issuing.
Each statement should include the name of the product, sufficient quotation
from the label to identify the brand, size, etc., the date of shipment,
where the shipment originated, and where and to whom it was consigned.
When there is more than one sample, show sample numbers in parenthesis
following the description of each shipment. If there is insufficient space
on the form to enter the samples and shipments involved, enter the notation
"See Page 2" conspicuously in the body of the Notice and continue
the additional information regarding the samples on a separate page captioned
as follows: "Page 2 - Section 305 Notice"
NOTE: When charging violations involving items other than shipments,
include a concise factual statement of the violation (see Exhibits).
Following the words "A meeting will be held on," insert the
day, date, specific time and place where the meeting will be held. Any
other information which may facilitate the citee's appearance may be added
in parenthesis following this statement, if desired (i.e. availability
of parking near the building).
The name of the Compliance Officer who will conduct the meeting should
be typed in at the bottom of the form and that individual should sign the
copies mailed to the firm and each individual cited.
If individuals have been cited along with the firm, show distribution
on all copies of the Notice under the parenthetical statement: "(IMPORTANT:
NOTE ALL ENCLOSURES CAREFULLY)" such as: 1 cc to Mr. John Doe and
to Mr. Robert Roe ea. w/cc Charge Sheet and Info. Sheet.
Charge Sheet (FD-1854)
Use form FD-1854. Under the title, list in ascending numerical order
each sample and product. When the list is long arrange in two columns.
Under the heading "Prohibited Act" state the section(s) of
the law(s) violated and the statutory description from the law. In charges
involving Title 18 or Title 42, cite those laws.
At the left of the sheet, following the above paragraph type the word
"CHARGES". If only one sample and charge is involved, enter the
statement "The article is violative in that" followed by the
nonlegal description of the violation. In the case of multiple charges,
enter the statement: "The article is violative in the following respects:"
and list each charge separately, numbered as "1," "2,"
"3," etc.
When a number of samples and charges are involved, use the statement
"The articles are violative in the following respects:" and list
the charges as described above. Show the sample numbers involved at the
left of each charge.
Charges should be stated in "lay language" and no reference
to specific sections of the Act (other than the "Prohibited Act")
or regulations need be included. Examples of charges are contained in Exhibit
5-3.
Legal Status Sheet (FD-454) (Exhibit 5-4)
Enter the sample numbers involved in the citation in the upper right
of the form following the caption "Sample No."; and the date(s)
of alleged violations over the "(Date)" caption following line
"A." If more than two dates are involved, show earliest and latest
dates only; for example "3/3/94 thru 4/12/94." No other entries
are made by the district office.
Information Form (FD-466a) (Exhibit 5-5)
This form describes the purpose and nature of the meeting. It is not
necessary to type any information on the form, however, it is mandatory
that a form accompany the Section 305 Notice sent to each individual cited.
DISTRIBUTION OF CITATION DOCUMENTS
After the Section 305 Notice and Charge Sheets have been prepared and
the Legal Status Sheets identified, distribute as follows:
Send the signed original copy of the section 305 Notice, Charge Sheet,
Information Form,. and a copy of the Legal Status Sheet to the primary
citee (generally the firm).
Send one signed carbon copy of the Section 305 Notice, accompanied by
copy of the Charge Sheet and an Information Sheet, to each of the other
citees if it is a joint citation.
Forward one copy of the Section 305 Notice, together with one copy of
the Charge Sheet to HFA-224 plus copies to the Factory File, reading file,
and, if applicable, to the District Resident Post.
Retain three copies of the Section 305 and Notice and Charge Sheets
in the District Sample File for use at the time recommendation for disposition
of the charges is made.
MAILING INSTRUCTIONS
Mail the Section 305 Notice in a regular, letter size envelope on which
the name and address of the citee has been typed. Do not use window envelopes.
When individuals are being cited along with a firm, circle or underline
their names on their respective copies and mail each citee's copy in a
separate envelope. Where the interests of the individual citees may be
at odds, you may send the individual notices to the home address of the
citee.
The Section 305 Notice should be sent by certified mail with return
receipt requested.
POSTPONEMENT OF MEETINGS
Districts may grant a reasonable postponement of a meeting upon written
request by a citee or person representing a citee (see exception below).
The length of the postponement will depend on particular circumstances,
but excessive delay should be avoided. Confirm the new date by a letter
to the citee or representative who requested the postponement. Provide
an information file copy to the Administration.
Exception: On occasion headquarters, in providing citation instructions,
may direct scheduling the meeting within two or three days for specified
reasons. Do not agree to postponements in such cases without first consulting
the issuing office.
TRANSFER OF MEETING
Occasionally citees will request that a schedule meeting be transferred
to another city in the district area, to another district office, or to
Washington headquarters. The citee has the option of answering by other
means when personal appearance at district headquarters is impractical.
The cost to the public of holding the meeting in another city outweighs
any benefit or convenience to the citee.
Transfer Within District Area
Do not grant requests for transfer of the meeting to another city in
the district area.
Transfer to Another District
Requests for transfer of a meeting to another district may be granted
if justifiable reasons are presented in writing. See 21 CFR 7.84(a). Before
granting the request, check with the District involved to make sure it
can handle the transferred meeting.
When the request is granted, verify the transfer by letter to the citee,
providing an information copy to HFA-224. Send two copies of the letter
to the transferee district with:
o The complete file on the samples involved
o Pertinent EIR's
o A DPU printout of firm's record, if pertinent to the case
The home district should establish a temporary jacket as a record of
the transfer.
The transferee district will reschedule the meeting promptly and advise
the citee accordingly. This may be done by letter with reference to the
original Section 305 Notice and letter approving transfer from the original
district. Forward copies to the home district and HFA-224.
After the meeting, send the Record and any exhibits to the home district
along with the original files.
Prepare a skeleton sample jacket containing a copy of the Record, stenographer's
notes, and copies of any collateral correspondence which may have issued
on the case.
Transfer to Headquarters
Requests by citees, before or during a meeting, for transfer of the
meeting to headquarters should be discouraged.
If, however, the citee insists that the meeting be held in headquarters,
refer the request to the center involved. If granted, the center will inform
the citee and home district of the new date set for the meeting. The district
should then promptly forward its case file to the center for review and
use during the meeting. The center will return the case file with the Record
to the home district for disposition of the charges.
CORRESPONDENCE WITH ATTORNEYS
Attorneys representing clients who have received a Section 305 Notice
will often correspond with the district compliance officer regarding the
Section 305 Notice. Because the issuance of a Section 305 Notice is confidential
and generally may not be publicly released until all potential criminal
matters are resolved, district compliance officers should assure persons
representing the citee provide appropriate documentation regarding representation.
See 21 CFR 7.84(g). As a rule, districts should not send copies of such
incoming correspondence to the citees.
Assume that the attorney is representing the citee and will bring to
his attention any information that he considers pertinent. However, copies
of responses to correspondence may be sent to the citee when the incoming
communication from the attorney shows distribution to the citee.
DRUG ADVERTISING CITATIONS
Due to the specialized nature of medical advertising, the review of
such advertisements is primarily done by the Division of Drug Marketing,
Advertising and Communications (DMAC), Center for Drug Evaluation and Research
(CDER). With few exceptions, citation on violative drug advertisements
will be initiated by that division.
Upon determining that an ad is violative and citation is warranted,
the division will initiate a request for samples to support an action.
Samples obtained will be routed to the home district of the responsible
firm.
The division will prepare citation instructions for the signature of
the Director, Office of Drug Standards, CDER, for issuance of the appropriate
district. The instructions will specify if the meeting is to be held at
the district, or at headquarters. In most cases, the meetings will be at
headquarters.
The district will issue the Section 305 Notice in the normal manner,
with a copy to DMAC.
Following the meeting, the division will make a decision on disposition
of the charges, and notify the district of that decision.
EXHIBITS
5-1 Model Section 305 Notice
5-2 Model Charge Sheet
5-3 Model Charges
5-4 Legal Status Sheet
5-5 Information Sheet
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SUBCHAPTER
DETENTIONS
BACKGROUND
Authority to detain meat, poultry and egg products under the provisions
of the Federal Meat Inspection Act (MIA), the Poultry Products Inspection
Act (PPIA) and the Egg Products Inspect Act (EPIA), are delegated by those
Acts to the Food and Drug Administration. This chapter contains the procedures
for exercising this authority.
For the purpose of this Chapter only, the following definitions are
applicable:
MEAT AND MEAT PRODUCTS
The carcasses of cattle, sheep, swine, goats, horses, other equines,
parts of such carcasses, and products made wholly or in part from such
carcasses.
POULTRY AND POULTRY PRODUCTS
The carcasses of domesticated birds, parts of such carcasses, and products
made wholly or in part from such carcasses.
EXCEPTION
In the case of both meat and poultry products, certain products are
exempted from the Acts by U.S.D.A because they contain a relatively small
portion of meat or poultry, or historically have not been considered meat
or poultry products.
EGGS
The shell eggs of the domesticated chicken, turkey, duck, goose or guinea.
EGG PRODUCTS
Dried, frozen or liquid eggs, with or without added ingredients, except
products exempted by U.S.D.A. because they contain a relatively small proportion
of eggs or historically have not been considered egg products.
AUTHORITY
The Federal Meat Inspection Act (MIA) as amended by Public Law 90-201
and Sections 19 and 20(b) of the Poultry Products Inspection Act (PPIA)
as amended by Public Law 90-492 and Section 19 and 23(d) of the Egg Products
Inspection Act (EPIA) provide certain detention powers.
The detention authority under the Federal Meat Inspection Act (MIA)
and the Poultry Products Inspection Act (PPIA) provide that FDA representatives
may detain articles subject to these acts if they are found outside a U.S.D.A.
inspected plant and there is reason to believe that the products are adulterated
or misbranded under the FD& C Act.
The detention authority under the Egg Products Inspection Act (EPIA)
provides that FDA representatives may detain products subject to that act
if they are found outside a U.S.D.A. inspected plant and there is reason
to believe that the products are in violation of the Egg Products Inspection
Act.
NOTE: Interstate Commerce is not a requirement for FDA jurisdiction
over eggs and egg products since authority is based on violation of the
Egg Products Inspection Act rather than the Federal Food, Drug, and Cosmetic
Act.
PROGRAM POLICY
The detention process is another regulatory tool to achieve compliance
with the FD& C Act. It should be considered when such products are
encountered during regular District operations, on assignment, or as a
follow-up to complaints. This procedure becomes most appropriate when no
immediate arrangements can be made for local or state authority to take
control of the product, and/or it appears that the product will not be
held voluntarily.
CRITERIA FOR EFFECTING AND TERMINATING DETENTIONS
The following procedures will be utilized in a detention situation:
EXERCISE OF DETENTION AUTHORITY
Meat and Poultry Products
Detentions may be made when all of the following criteria are met:
1. The article meets the jurisdictional requirement of interstate commerce
of Section 304 of the FD& C Act and the article is in commercial channels.
2. The article is located in an establishment that does not have U.S.D.A.
meat or poultry inspection service.
3. The article is intended for human food or could be readily diverted
into use for human food.
4. The article is adulterated or significantly misbranded under the
FD& C Act. (NOTE: Detentions based solely on misbranding or on adulteration
involving Section 402(b) of the FD& C Act must be cleared before detention.
EGGS AND EGG PRODUCTS
Detention may be made when all of the following criteria are met:
1. The article is in commercial channels (NOTE: Interstate commerce
is not a requirement for jurisdiction under the Egg Products Inspection
Act.)
2. The article is located in an establishment that does not have U.S.D.A.
egg products inspection service.
3. The article is intended for human food or could be readily diverted
into use for human food.
4. There is reason to believe the article is in violation of the Egg
Products Inspection Act.
TERMINATION OF A DETENTION ACTION
Detention should be continued until one of the following criteria is
met:
1. State, County or municipal authorities have exercised jurisdiction
and control of the article; or, in the case of meat or poultry, U.S.D.A.
has assumed control.
2. It has been determined that there is no significant violation of
the Federal Food, Drug, and Cosmetic Act, or the Egg Products Inspection
Act, and the U.S.D.A has been notified that we intend to terminate the
detention action.
3. The detained article has been denatured, destroyed or reconditioned
under appropriate supervision.
4. The detention period of 20 consecutive days, counting the day detention
was executed as the first day, has expired.
5. Seizure has been accomplished.
NOTE: Seizure recommendation should be forwarded as soon as possible
after detention is accomplished, since detention cannot be reinstated after
the 20 day expiration period.
PROCEDURES
The procedures in this subchapter have been identified for review and
possible revision. A revised subchapter will be issued upon completion
and clearance of revisions.
Specific inspectional instructions including initial reporting requirements,
detention initiation, reconditioning and termination are contained in the
Investigations Operations Manual, Chapter 7, subchapter on "Detention
Activities".
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SUBCHAPTER
ADMINISTRATIVE DETENTION OF DEVICES
PURPOSE
This guide provides the procedures and defines responsibilities for
the various operations involving Administrative Detention of Devices.
DETENTION OF DEVICES
GENERAL INFORMATION, POLICIES, RESPONSIBILITIES, ETC.
Background
Section 304(g) of the Federal Food, Drug, and Cosmetic Act added to
the law by the Medical Device Amendments of 1976, authorizes the detention
of devices in accordance with regulations for a period of up to 30 calendar
days (see page 139, "Length of Detention") if during an inspection
the FDA has reason to believe the devices are adulterated or misbranded.
Regulations have been established for the detention of devices intended
for human use. Administrative detention is intended to protect the public
by preventing distribution or use of violative devices until the FDA has
had time to consider the appropriate action to be taken and, where appropriate,
initiate legal action. Detention of devices requires prior approval from
the director of the district in which the devices are located.
Any person who would be entitled to claim the devices, if seized, may
appeal the detention and may request a hearing on the appeal. The decision
to affirm or revoke the detention must be made within five (5) working
days of receipt of the appeal if no hearing is requested or if a hearing
is requested within 5 working days after the appeal is filed. If the hearing
is requested for a date more than 5 working days after the appeal is received,
the decision must be made within 5 working days after the conclusion of
the hearing.
It should be noted that responsibility for administering the medical
device amendments is divided between the Center for Drugs and Biologics
and the Center for Devices and Radiological Health.
References
The regulatory authority for administrative detention and associated
operations appear in Section 304(g) and 201(y) of the FFD& C Act, 21
CFR 800.55, 21 CFR Part 16, 21 CFR 5.47, and 21 CFR 10.19. The IOM Subchapter
750 contains the instructions for implementation of the detention authority.
Detention Policy
District directors should assure themselves that the agency will support
an administrative detention based on the adulteration and/or misbranding
violations detected prior to approving the detention order. This will include
as a minimum contact with the senior compliance official in the appropriate
center. This process will assure that recent policy developments or changes
(not yet communicated to the field) are considered. It will also provide
notice to headquarters of the impending legal action recommendation.
Contacts are:
1. Director, Office of Compliance (HFZ-300), CDRH (301) 594-4692 or,
if a biological device:
2. Director, Office of Compliance (HFM-600), CBER (301) 594-2066.
Concurrence will be by telephone. It is not intended that written documentation
be provided by either field or headquarters, except for cause, for example
issues of science, policy or law involving precedent or questionable facts.
If the district director concludes that the person in possession of
the device(s) will voluntarily hold the product, provide assurance that
integrity and security will be maintained over the stocks on hand, and
agrees to correct the violation(s) prior to shipment, detention need not
be undertaken.
Approval of Detention Order By The District Director
A detention order, before issuance, must be approved by the district
director, either orally or in writing. If the approval is oral, it must
be reduced to writing as soon as possible.
Detention Order Issuance
The order shall be signed by an investigator or other authorized agent.
The order must be issued in writing to the owner, operator, agent, or other
responsible person in charge of the place where the device is located.
At the time the order is issued the opportunity for appeal and hearing
on the detention as noted on the order should be pointed out by the FDA
investigator to the owner or agent or other responsible person who is in
receipt of the order.
If the order is not issued to the owner or agent of the owner of the
device, then as quickly as possible a copy of the detention order and a
copy of 21 CFR 800.55(g)(1)& (2) will be sent by the district to the
owner, via certified mail return receipt requested.
Form of Order
The detention order is issued on Form FDA 2289 Detention Notice.
Instructions for completion of the form are found in subchapter 751
of the Inspection Operations Manual.
The detention order frames the issues of any appeal or informal hearing
which may result from the detention; therefore, the information on the
order concerning the reason for detention is very important.
The order is not required to include all of the reasons for believing
the product is adulterated or misbranded; only the more significant violations
should be listed. However if a statutory ground of adulteration or misbranding
isn't listed in the order, it may not be relied on to support the detention.
The charge in the order should be stated in factual non-statutory language.
For example, if the investigator finds a sterile, individually packaged
syringe in which the packages have holes along the seams, black greasy
spots on the needle, and the label lacks the Zip Code of the manufacturer,
the reason for detention should state the apparent violation as "there
is reason to believe the device is:
1. Adulterated per section 501(a)(2)(A) of the act in that there are
holes in the package and black spots on the needles. The product has been
prepared, packed, or held under insanitary conditions whereby it may have
been rendered injurious to health.
2. Misbranded per section 502(a) in that the label states that it is
sterile and the integrity of the package is compromised by holes."
The labeling is false and misleading. (Note: a "continuation sheet"
may have to be used in order to provide sufficient space.)
Note: Charges used in the detention order do not necessarily limit the
charges that may be identified in a subsequent complaint filed in court.
Length of Detention
A detention will be for 20 calendar days unless the district believes
that additional time will be required to accomplish a legal action. In
such cases, the detention should be made for 30 calendar days at the time
the order is issued. When a detention is extended from 20 to 30 days, another
detention order must be issued and new tags put on the devices.
The detention can not last for longer than 30 calendar days.
Movement, Use, etc. of Detained Devices
Except as noted below, without the written permission of the agency,
devices cannot be moved, used, altered, or tampered with in any manner
once they are detained; therefore, at the time of detention, the investigator
should, if possible, have the devices moved to a location where they will
be segregated from other devices or products and will remain undisturbed.
With the approval of the district director, the investigator who detained
the devices or any other responsible district official may authorize in
writing the movement of detained material. Whoever moves the devices must
immediately notify (orally) the authorizing official where the devices
were relocated.
The only exception to the prohibition on movement without written permission
is when the goods are not in final form for shipment and the manufacturer
wants to complete work on them. The manufacturer may move them within the
facility, where they are detained, to complete manufacture, but must orally
notify FDA of the movement as it occurs. When manufacturing is completed,
the manufacturer must immediately segregate the detained devices from other
products and orally notify FDA of their new location.
However, the manufacturer may not move the devices from the establishment
without prior written approval of the district director as referenced above.
Note: 21 CFR 800.55(h)(2) prohibits further movement even within the
establishment without FDA approval.
Legal Actions Against Detained Devices
Recommendations for legal actions involving detained devices should
be developed by the recommending district on an expedited basis, flagged
to indicate that the goods are detained and the date the detention expires,
and forwarded to the responsible center compliance office using overnight
delivery services.
The center compliance office, ORA, and General Counsel will process
the recommendations on a priority basis to accomplish the legal action
prior to expiration of the detention.
The district is responsible for monitoring the length of the detention
and the progress of the recommendation. If a 20 day detention will expire
prior to accomplishing the legal action the district should extend the
detention for an additional 10 days.
The district is responsible for coordination with the U.S. Attorney's
office and the Marshal's Service to assure that the complaint is promptly
filed and the goods seized.
The district is responsible for immediately providing oral notice of
the accomplishment of the legal action to the appropriate center compliance
office, GC, and the presiding officer of any in process appeal of a detention
order.
Recordkeeping Requirements
At the time of issuance of a detention order, or as soon as possible
thereafter, the district should inform the owner, operator, or agent in
charge (of the establishment where the devices are detained) of their responsibility
to establish or maintain records as required by 21 CFR 800.55(k).
Termination of Detention Orders
Detention orders will be terminated for the following reasons:
1. Determination by FDA that the devices are not violative.
2. FDA approved voluntary destruction or compliance by reconditioning
or other means (e.q. relabeling).
3. Revocation of the detention on appeal.
4. Accomplishment of regulatory action against the product. Actual seizure
or entry of TRO or an order by consent or otherwise of preliminary injunction.
The filing of a complaint does not necessarily terminate a detention order.
5. Expiration of the detention period.
Termination of detention orders must be approved by the district director
within whose district the material is located. Such approval may be oral
or written, and if oral, it shall be later confirmed in writing. The Detention
Termination Notice (FDA-2291), is issued to the person(s) to whom Detention
Notice was issued, or his representative; and, if the devices were moved
prior to the termination, to the person possessing the devices. The notice
may be issued in person or by mail. The Detention tags (FDA-2290) should
be requested to be returned if the termination is handled by mail. See
IOM 751 for instructions on termination in person. A statement required
by 21 CFR 800.55(k)(2) must be issued advising the owners, operators, or
agents in charge to keep the records concerning the detention for the remainder
of the two year period from the date of detention or such shorter period
as FDA directs.
DISTRICT RESPONSIBILITIES
As referenced above, the district is responsible for:
1. Assuring support from the senior compliance official of the appropriate
center before issuing a detention order.
2. Issuing the detention order.
3. Notifying ORA (Director, DCMO) by phone of the detention and supplying
that person with a copy of the detention order by the most expeditious
means available (fax, express mail, etc.) immediately after issuance.
4. Approving and monitoring the movement of detained devices.
5. Notifying the regional director that the district has issued a detention
order. NOTE: The RFDD must be kept insulated from detention after the detention
has been put in place in order to avoid even the appearance of bias or
prejudice.
6. Pursuing the follow-up legal action as discussed on this page under
the heading, "Legal Actions Against Detained Devices."
CENTER COMPLIANCE OFFICE RESPONSIBILITIES
District contact with the center, for concurrence, will be a routine
procedure. A detention order may not be issued if the director for compliance
of the center will not support the proposed detention. Concurrence to the
district can be afforded by phone, by EMS, or other expedited communication.
A formal submission of documents supporting detention will generally not
be necessary by either party.
The compliance office will quickly review any information provided by
the district, through ORA, alert the district, ORA, and GC of any problem
areas, and forward to the district all requested documents. The compliance
office will provide expert witnesses and other support, as appropriate.
GC RESPONSIBILITIES
GC will quickly review any information provided by the district, through
ORA, and alert the district, the center office, and ORA, of any problem
areas, prior to the detention being put in place.
Staff assignments in GC shall be made by the Deputy Chief Counsel for
Litigation or the Deputy Chief Counsel for Regulations and Hearings, and
preliminary preparation begun for any such appeal. Appropriate compliance
offices at the center and ORA shall be notified of the attorney chosen
to represent the district on any such appeal.
ORA RESPONSIBILITIES
Upon notification that a detention has been effected or a subsequent
appeal received by the district:
1. ORA (DCMO) will immediately notify the center compliance office (CCO)
and GC (Deputy Chief Counsel for Litigation or Deputy Chief Counsel for
Regulations & Hearings) and deliver a copy of the detention order request
for hearing, or other documents, to them. ORA will coordinate the detention
to ensure that all agency and GC components are notified of and prepared
for a hearing in a timely way.
2. GC (Deputy Chief Counsel for Litigation or the Deputy Chief Counsel
for Regulations and Hearings) must also be notified of each appeal and
afforded the opportunity to consult as to whether the district and the
RFDD require counsel.
3. ORA will ensure that all documentation from the district in support
of the detention/hearing is provided to CCO & GC.
RFDD RESPONSIBILITIES
The RFDD must insulate himself/herself, after the detention has been
put in place, from all aspects of a detention except those relating to
his/her responsibilities as a presiding officer. Responsibilities at that
time are found in the next section, "Appeal of a Detention Order."
APPEAL OF A DETENTION ORDER
GENERAL INFORMATION
Background
Section 304(g) of the act permits anyone who would be entitled to claim
the goods, if they had been seized, to appeal a detention order.
If the detention is appealed, section 304(g) requires that the agency
afford the appellant with an opportunity for an informal hearing. If the
appellant does not request an informal hearing the decision to affirm or
revoke the detention shall be rendered within 5 working days after the
filing of the appeal. If the appeal includes a request for an informal
hearing the appellant shall request either that a hearing be held within
5 working days after the appeal is filed or at a later date, but not later
than 20 calendar days after receipt of the detention order (21 CFR 800.55(g)(1).
If the appellant requests a hearing within 5 working days after the appeal
is filed, the presiding officer shall hold the hearing and render a decision
within 5 working days of the filing of the appeal. In the event of a request
for a delayed hearing, the hearing shall be scheduled after the 5th working
day following the appeal, and a decision shall be issued within 5 working
days of the hearing's conclusion.
Regardless of the scheduling of the hearing, no detention may be extended
past the 30 calendar day detention period without the consent of the appellant.
(The provision for extension of the detention found in 21 CFR 800.55(g)(6)
is incorrect, and should not be followed.)
Time to Appeal
The regulations allow an appellant 5 working days from the receipt of
the detention order (which also serves as a notice of opportunity for a
hearing) to appeal the detention with or without a request for an informal
hearing. The appeal is to be in writing, addressed to the district director
of the district office within whose area the goods are detained, and shall
contain a statement (in writing) asserting that interest (e.g., ownership)
in the detained goods that would qualify the appellant to claim the goods
if they were to be seized. The 5 days will be determined by the postmark
on the appeal letter.
The district director will allow 1 day of additional time for the receipt
of an appeal request. Additional time should be allowed if the appellant
can show that it was not possible to appeal earlier.
Presiding and Deciding Official
The Regional Food and Drug Director (RFDD) for the region in which the
District is located and in which the goods were detained shall be the presiding
and deciding official unless he/she disqualifies him/herself (21 CFR 800.55(g)(4),
21 CFR 16.40 and 16.42, and 21 CFR 5.47). In the event of disqualification,
the RFDD will immediately arrange for another RFDD to preside and provide
immediate notification of any such change to the district director and
the appellant.
Communications Between Parties to the Hearing And
the Presiding Officer
Any off the record communication between parties to the hearing and
the presiding officer should be avoided. If such a communication occurs,
it shall be reduced to writing and made a part of the record. A memo of
any such communication of the type which would affect the presiding officer's
decision shall be provided to the other party by the presiding officer
with an opportunity to respond (21 CFR 16.44(b)).
Any written communication between a participant in the hearing and the
presiding officer is to be sent to all participants by the person originating
such communication (21 CFR 16.44(c)).
APPEAL PROCESSING DISTRICT RESPONSIBILITIES
When the district decides it is going to detain a device(s), it will
also begin to prepare for an appeal of the detention so that if a hearing
is requested within 5 working days of the filing of an appeal, the hearing
can be held and a decision rendered in a timely manner (that is, within
5 working days of the appeal).
When an appeal is received by the district, the director shall:
1. Date and time stamp the appeal and notify the appellant of the receipt
of the appeal. If the appeal does not specify that a hearing is or is not
requested, does not demonstrate ownership or proprietary interest as required
in 21 CFR 800.55(g)(1) and (2), or does nor specify the time period within
which a hearing is to be held (see RPM page 141, "Background - Appeal
of a Detention Order"), contact the appellant and clarify this information.
Any declaration of ownership or proprietary interest must be made in writing.
2. Orally notify the RFDD and the Director, DCMO of the appeal immediately
and forward a copy of the appeal to them as soon as possible. Request assistance
of the General Counsel and the appropriate center for completing the next
item.
3. When the appeal includes a request for a hearing:
a. Prepare (1) a general summary of the information which will be used
to support the detention and (2) a Comprehensive Statement of the basis
for the action. The Detention Order (notice) may serve as the Comprehensive
Statement only if the reason for detention is described in sufficient detail.
See Exhibits 5-6 and 5-7 for an example of a general summary and a comprehensive
statement respectively. See Exhibit 5-8 for examples of reasons detailed
enough for the FDA 2289 to serve as a comprehensive statement.
b. Forward the general summary and Comprehensive Statement to the appellant
(21 CFR 16.24(f) and 201(y)(3)) and a copy to the RFDD and any office and
GC representative to the hearing to arrive as soon as possible, but at
least one day prior to the hearing.
c. At least one day before the hearing, provide the appellant, the RFDD,
and any office and GC representatives to the hearing, written notice of,
or a copy of, if they could not reasonably be expected to obtain a copy,
any published articles or written information to be presented at or relied
on at the hearing (21 CFR 16.24 (g)).
4. When the appeal does not include a request for hearing, forward all
the information the district wishes to use in support of the detention,
including the referenced general summary and comprehensive statement, and
any additional information provided by the appellant, to the RFDD acting
as the deciding official to arrive within sufficient time to be reviewed
and for a decision to be rendered within 5 days after receipt of the appeal.
Appeal Processing Presiding RFDD Responsibility
When notified of an appeal, the RFDD must:
1. If a hearing is requested,
(a) orally contact the parties as soon as possible and, depending on
the time period within which the appellant requests a hearing, either set
a hearing date and time to allow for a decision within 5 working days after
the date of receipt of the appeal by the district, or set a hearing date
and time later than 5 working days after receipt of the appeal by the district,
but not later than 20 calendar days after issuance of the detention order.
The hearing should normally be held at the district office of the district
where the goods are located.
(b) provide all parties with written notification of the time, date,
and location of the hearing.
(c) provide the appellant with oral and written notification (see form
letter as Exhibit 5-9) of the following:
(1) Notification of those portions of 21 CFR Part 16 that are excluded
or modified under 21 CFR 800.55(g) (3) and are waived or modified for hearings
on appeal of administrative detentions (See page 143, "Informal Hearing
on Appeal of a Detention Order."
(2) Notification that the informal hearing is not a public hearing per
section 16.60(a) of the regulations, in order to protect investigatory
records compiled for law enforcement purposes that are not available for
public disclosure under 21 CFR 20.64, or trade secret material under 21
CFR 20.61.
(3) Notification that the appellant should provide, at the hearing,
a brief summary of any lengthy documents to be presented at the hearing
(e.g. volumes of computer printouts).
(4) Notification that if feasible, at least one day before the hearing,
the appellant should provide the district director written notice of, or
a copy of (if the district director could not reasonably be expected to
obtain a copy), any published articles or written information to be presented
at or relied on at the hearing as required by 21 CFR 16.24(g).
(5) Notification of the requirements under 21 CFR 16.44(c) (see page
142, "Communication Between Parties to the Hearing and the Presiding
Officer." )
2. If an appeal is made but no hearing is requested, the presiding officer
shall immediately orally notify the parties to submit information supporting
their positions as soon as possible so that the information can be reviewed
and a decision reached within 5 working days of the receipt of the appeal.
Additional information submitted prior to the decision will be accepted.
The presiding officer should also orally notify the appellant of the requirement
under 16.44(c) (see page 142, "Communication Between Parties to the
Hearing and the Presiding Officer.")
3. When advice of the General Counsel is needed, contact the Deputy
General Counsel for Litigation.
INFORMAL HEARING ON APPEAL OF A DETENTION ORDER
Section 304(g) of the Act states that upon appeal of a detention order,
the agency will afford the appellant with an opportunity for an "informal
hearing." Section 201(y) of the Act defines an informal hearing and
lists specific provisions. 21 CFR 800.55(g)(3) provides that 21 CFR part
16, Regulatory Hearing, establishes the procedures for conducting the informal
hearing. Section 16.5 of the regulations advises that part 16 procedures
apply to the extent that they are supplementary to and not in conflict
with other procedures specified for the hearing. Section 16.60(h) gives
the presiding officer the power to suspend, modify, or waive provisions
under part 16.
WAIVERS, MODIFICATIONS, ETC. TO 21 CFR PART 16
21 CFR 800.55(g)(3) waives the following parts of 21 CFR 16:
1. 16.22(a) (formerly 16.24(a)) concerning the issuance of a separate
notice of opportunity for hearing because the detention notice FDA 2289
serves that function under 21 CFR 800.55(g) (3)(i).
2. 16.22(b) (formerly 16.24(b) concerning the appeal being sent to the
presiding officer because 21 CFR 800.55 (g)(1) requires that the appeal
be sent to the district director.
3. 16.24(d) (formerly last sentence of 16.24(c)) concerning not permitting
the hearing to be held within 2 days of the receipt of the appeal because
time constraints can not allow for such a restriction.
4. 16.42(a) (formerly 16.40(a)) regarding those persons who may act
as the presiding officer because 21 CFR 800.55(g)(4) only allows RFDDs
to be presiding officers.
The presiding officer has the authority to waive, suspend, or modify
any of the provisions under part 16 (21 CFR 10.19 and 21 CFR 16.60(h)).
The following other provisions shall be waived or modified by the presiding
officer:
5. 16.60(f) which requires the hearing officer to make a recommended
decision with statement of reasons to the deciding official because the
RFDD performs both functions.
6. Sections 16.95(b)(1) & (2) which state that the Administrative
Record of a Regulatory Hearing (16.80(a)(1)-(5)) is the exclusive record
and basis for the decision, will be modified. The decision will be based,
in most cases, on all information presented to the presiding officer prior
to or during the hearing. The decision will not be based on the following
information or documents, if they are not received or completed by the
presiding officer within the time period necessary for the presiding officer
to review or complete them prior to making the decision as required by
the Act or regulation:
a. Information and views submitted to the presiding officer after the
hearing is not part of the official record unless the presiding officer
permits post-hearing submissions and information is submitted within the
period specified by the presiding officer (16.80(a)(2)).
b. Any transcript of the hearing (16.80(3)).
c. The presiding officer's report of the hearing and comments on the
report under 16.60(e) (16.80(4)).
7. That part of section 16.60(b) is waived which provides that all parties
may confront and conduct reasonable cross-examination of any person (except
for the presiding officer and counsel for the parties) who makes any statement
on the matter at the hearing. Reasonable questioning will be allowed instead.
Reference congressional intent: House of Representatives Report no. 94-853.
Also see 21 CFR 16.5 and 16.60(h).
CENTER OFFICE RESPONSIBILITIES
The center will provide documents, witnesses, or office representatives
for the hearing if requested by the district or the GC attorney counselling
the district.
GC RESPONSIBILITIES
GC will provide counsel for the district and/or the presiding officer,
as appropriate, for the hearing.
DISTRICT AND PRESIDING RFDD RESPONSIBILITIES
The individual responsibilities of the district and the presiding RFDD
are included in the discussion below on "Conducting the Hearing".
CONDUCTING THE HEARING - GENERAL
PROCEDURES/RESPONSIBILITIES
The presiding officer should at the onset remind the parties of the
modifications to part 16 that apply and explain the purpose or issue of
the hearing. The issue at the hearing is whether the FDA had reason to
believe the devices were adulterated or misbranded at the time of the detention
and as charged in the detention order, and not whether the law has in fact
been violated. That question is properly left to the court trial, if one
is held.
The FDA representative(s) will be present to explain the bases for the
detention and answer reasonable questions from the appellant.
The appellant will then present relevant information and reasons why
he believes the agency did not have reason to detain the product.
The FDA representatives may then ask reasonable questions. (201(y)(4)).
The presiding officer shall assure that the material presented and the
questions asked are relevant to the issue of the hearing.
A transcript of the hearing may be requested by the appellant; however,
he/she must pay the cost of it and furnish the presiding officer a copy
for the record. The agency can also request a transcript of the hearing
and the costs will be borne by the government.
If the appellant wishes a copy of the government transcript, he/she
may obtain it via a Freedom of Information Act request. 21 CFR Part 20
applies to the release of the transcript.
The presiding officer shall notify the parties that his decision will
not await transcription or correction of the transcripts so ordered.
REQUIREMENTS AFTER A HEARING ON APPEAL OF A DETENTION ORDER
PRESIDING RFDD RESPONSIBILITY
Confirming or Revoking the Detention Order
1. Time Period for Rendering Decision
As referenced on page 141, "Appeal of a Detention Order - Background,"
the presiding officer must by order, confirm or revoke the detention order
within five (5) working days of the receipt of the appeal by the district
director, if no hearing is requested or if a hearing has been requested
within 5 days by the appellant. However, if the appellant requests a hearing
later than the referenced 5 working day time frame, but not later than
20 calendar days after issuance of the detention order, then the presiding
officer must, by order, confirm or revoke the detention order within five
(5) working days after the close of the hearing (21 CFR 800.55(g)(5) and
(6)). The detention may not be extended past the otherwise applicable 30
day period (See page 141, "Background - Appeal of a Detention Order")
without the consent of the appellant.
2. Basis for Rendering Decision
If the agency can show that it had a reason to believe the devices were
adulterated and/or misbranded at the time of the detention under one or
more of the charges in the detention order, the presiding officer will
affirm the detention order. If not, the detention order will be revoked.
3. Issuance of the Order
The decision is issued in the form of an order (See Exhibit 5-10 for
model order.) The parties to the appeal should be orally notified of the
order immediately. Copies of the order should then be mailed to the parties
(certified mail return receipt requested).
The decision which is rendered on the detention must be ordered within
the above time frames, however, the completion of the written decision
and report of the hearing (discussed below) can not delay the order. It
is anticipated that the order will be consolidated with the written decision
and report of the hearing, and this will normally be done. Additional time
may however occasionally be necessary to complete the written decision
report of the hearing and in that case it will be separate from and will
follow, shortly, the order.
Written Decision and Report of Hearing
The presiding officer shall prepare a written decision to include the
reasons and basis for his decision (16.95(b)(2)). The written decision
shall include the report of the hearing required by section 201(y)(5) of
the Act and 21 CFR 16.60(e). All written material submitted during the
hearing must be attached to the written decision/report of the hearing
(201(y)(5) of the Act and 21 CFR 16.60(e)). Any transcript of the hearing
must also be included. Whenever time permits, the participants will be
given the opportunity to review and comment on the written decision/report
of the hearing, however, the presiding officer should set a time limit
for the participants to comment. (As previously noted, whenever possible,
the written decision/report of hearing should be issued with the order
as a single document).
Administrative Record of the Hearing
The presiding officer shall prepare the Administrative Record of the
Hearing which shall consist of the following:
1. The detention order and the appeal.
2. All written information and views submitted to the presiding officer
in conjunction with the hearing.
3. Any transcript of the hearing.
4. The presiding officer's written decision/report of the hearing and
order and any comments on the written decision/report of the hearing permitted
under 201(y) of the Act and 21 CFR 16.60(e).
5. All letters and memoranda of meetings and communications between
participants and the presiding officer referred to in 21 CFR 16.44(c).
The official administrative file should be forwarded for maintenance
with the official file of the firm at the district office after completion
of the report. A copy should be forwarded to the center involved for its
information and then filed in the administrative files (HFA-224). Another
copy should be maintained by the office of the RFDD that held the hearing.
FOI REQUESTS
21 CFR 20 applies to all requests for documents involved in administrative
detention.
EXHIBITS
5-6 General Summary
5-7 Comprehensive Statement
5-8 Examples of Detailed Statement
5-9 Model Hearing Confirmation Letter
5-10 Model Order
------------------------
SUBCHAPTER
LICENSE REVOCATION OR SUSPENSION
PURPOSE
This section contains procedures for revoking and suspending establishment
and product licenses issued under the Public Health Service Act.
"Act" means the Public Health Service Act (58 Stat. 702, 42
U.S.C. 262) approved July 1, 1944 (Amended).
"CBER" means the Center for Biologics Evaluation and Research.
"Biological product" means any virus, therapeutic serum, toxin,
antitoxin, vaccine, blood, blood component or derivative, allergenic product,
or analogous product, or arsphenamine or its derivatives (or any other
trivalent organic arsenic compound), applicable to the prevention, treatment,
or cure of diseases or injuries in man.
"License" is the authorization issued by CBER to an establishment
for the propagation, preparation, or manufacture of specific biological
product(s) for sale, barter, or exchange in interstate commerce.
"Regulations" referred to in this part are those promulgated
under the Act, including those in 21 CFR Parts 600 through 680.
"Revocation" is the cancellation of a license and the withdrawal
of the authorization to ship a biological product for sale, barter, or
exchange in interstate commerce either at the request of the manufacturer
or when grounds exist for the agency to initiate such an action.
"Suspension" is a summary action taken by the agency and may
be an intermediate step in the revocation process. Suspension provides
for the immediate withdrawal of the authorization to ship a biological
product for sale, barter, or exchange in interstate commerce when grounds
for revocation and a danger to health exist.
GENERAL
Licenses issued to establishments for the manufacture of specific biologic
products under the provisions of Section 351(a) of the Act, may be: 1)
revoked upon request of the licensee or by agency initiative when sufficient
grounds exist; or 2) suspended if there are grounds for revocation and
a danger to health.
Recommendations for suspension and revocation are reviewed by CBER and,
if concurred with, are forwarded to the Associate Commissioner for Regulatory
Affairs (ACRA) for his/her review, concurrence, and signature. Recommendations
for license revocation or suspension must be adequately supported with
evidence of violations of the applicable statutes and regulations.
GENERAL CONSIDERATIONS, REVOCATION
Revocation of an establishment or product license, or both, will be
considered when any of the conditions as specified in 21 CFR 601.5 exist.
When the establishment license relates to multiple locations, revocation
may be limited to one or more of the locations if inspectional findings
support that approach.
Before making a recommendation to revoke a license, the district should
consider whether there is evidence of willful noncompliance, or pervasive
or flagrant violations. If no such evidence exists, the district should
consider issuing a Warning Letter, as appropriate, rather than immediately
recommending revocation.
The licensee must be given the opportunity to request a hearing, pursuant
to 21 CFR 12.21(b).
GENERAL CONSIDERATIONS, SUSPENSION
Pursuant to 21 CFR 601.6, the Commissioner may suspend a license when
there are reasonable grounds for revocation of a license and a danger to
health exists. Documentary evidence to support revocation must be obtained
and the evaluation of danger to health completed by CBER before a recommendation
for suspension is implemented.
As in the case of revocation, when there are multiple locations encompassed
by one license, suspension may be limited to one or more of the locations,
if that approach is warranted.
PROCEDURES/GUIDANCE, REVOCATION
Because revocation actions do not encompass situations involving a danger
to health, procedures for submission of such proposed actions, where no
suspension of license has been recommended or effected, should track those
procedures used for Warning Letter submissions, i.e., the basis for considering
"such action," including complete documentation, is to be submitted
to the center. The center contact for revocations is the same as indicated
for suspensions.
PROCEDURES/GUIDANCE, SUSPENSION
After obtaining complete documentation of the violative conditions (including
guidance from CBER as necessary), a documentary sample (or physical sample,
if required), and an inventory of products which ar on the premises on
the last day of inspection, the investigator will consult with his/her
supervisor who will recommend appropriate regulatory/administrative action
to the district compliance office.
If the district believes suspension of license is appropriate, the district
compliance office will, on the day of inspection if possible, or early
the next morning, telephone CBER to recommend suspension of operations
under license. At that time, specific substantive information relating
to the violations (grounds for suspension) must be presented.
The initial CBER contact is the Director, Case Management Staff, HFM-610.
A compliance officer from HFM-610 will be assigned to each suspension recommendation.
The district shall confirm the verbal recommendation in writing in a
brief memo and shall include the grounds on which the recommendation is
based. It may be transmitted by FAX. A copy of the FD-483 shall also be
transmitted as quickly as possible to CBER by FAX or express delivery,
along with any additional requested preliminary information and/or documentation.
To avoid delay, do not send supporting documentation through the regular
mail system if other means of transmission are available. If using express
delivery, send to:
(The assigned center compliance officer1),
Case Management Staff (HFM-610)
Office of Compliance
Center for Biologics Evaluation and Research
Food and Drug Administration
7520 Standish Place, Rm 225
Rockville, Maryland 20855
1 Insert name of individual.
Recommendations for suspension should be given high priority in the
districts and supervisors must act promptly. Every effort should be made
to expedite the submission of a recommendation to CBER to suspend operations
under license at an establishment whose practices are jeopardizing donor
or recipient health and/or product safety.
If the district believes no danger to health exists, the district compliance
office will consider, and may recommend, other appropriate actions, e.g.,
Warning Letter, or revocation, depending on the seriousness of the problems
noted.
Frequently, CBER will decide to suspend a license after receiving the
FD-483, but before receiving the EIR.
In some cases, CBER may need to review the completed EIR before reaching
a decision. In either event, the EIR must be promptly written and forwarded
by express mail service to CBER.
Appropriate CBER personnel will review the information received and
determine whether suspension of the firm's operations is warranted.
If CBER concurs with the district's recommendation, it will prepare
an Action Memorandum and a letter of suspension for the signature of the
ACRA.
After the letter has been signed, the Office of Compliance, CBER will
telephone the Responsible Head of the establishment to advise him/her of
the deviations noted during the inspection and the suspension of the establishment's
operations under license effective with the call.
The district office will also be telephoned and advised of CBER's action.
Arrangements will be made, if possible, to transmit a copy of the suspension
letter to the district for hand delivery to the Responsible Head.
If CBER disagrees with the suspension recommendation, it will verbally
communicate its decision to the district compliance officer. CBER will
send a memorandum explaining the reasons for the disapproval to the district
office.
If CBER disagrees with the suspension recommendation based on the absence
of a danger to health, and any of the conditions specified in 21 CFR 601.5(b)
exist, CBER will consider whether it is appropriate to revoke the license
or send a Warning Letter.
Upon receipt at CBER, the reply to a letter of suspension will be reviewed
expeditiously, CBER will review the establishment's suspension letter expeditiously.
CBER and the firm will continue to correspond until all corrective actions
appear satisfactory. At that time, the establishment will be notified by
telephone (later confirmed by letter) that it may resume limited operations
for the purpose of a reinspection to determine that the corrective actions
have been implemented and are effective. The district office will be requested
to perform a follow-up inspection expeditiously, generally around 30 days
after resuming limited operations. At this time, CBER will supply copies
of all pertinent correspondence and documents to the district.
The district should advise CBER of the approximate date on which the
reinspection is scheduled and, immediately upon its conclusion, notify
CBER by telephone of its' findings and recommendation (call CBER contacts
as listed in the compliance program). This should be followed by a written
recommendation sent on the same day as the inspection. If an FD-483 is
issued, a copy of the firm's response, if any, should be forwarded to CBER.
A written copy of the establishment inspection report should be sent to
CBER as quickly as possible to support suspension/reinstatement determination.
In some instances the firm may have made significant progress in achieving
compliance but, after review of the FD-483 and the firm's response(s),
the district and/or CBER may view a limited follow-up inspection as necessary
prior to making a final determination as to whether to recommend reinstatement
of the license.
If compliance has been achieved, CBER will prepare an Action Memorandum
and letter of reinstatement for the signature of ACRA. After the letter
has been signed, CBER will telephone the Responsible Head and advise him/her
that suspension of the firm's activities has been lifted and products collected
or manufactured since the date they resumed limited operations may now
be shipped. The district will also be advised by telephone and will receive
a copy of the reinstatement letter, which will contain instructions to
the firm for filing an appeal to use any products in inventory at the time
of suspension.
After receiving and reviewing a firm's written appeal CBER will notify
the firm, in writing, of its decision regarding disposition of products
in inventory at the time of suspension (copy to the district). The district
may be requested to monitor the disposition of the inventory.
If the follow-up inspection indicates inadequate corrective actions
and continued deviations, additional documentation should be obtained and
CBER notified immediately. CBER will decide whether to allow the firm to
continue in limited operation or to suspend all operations. CBER will also
consider the possibility of proceeding toward revocation.
Copies of all correspondence, verbal and written
communications, and EIR's relating to suspensions of operations under
license should be sent to the attention of:
(The assigned center compliance officer1)
Case Management Staff (HFM-610)
Office of Compliance
Center for Biologics Evaluation and Research
Food and Drug Administration
7520 Standish Place, Rm 225
Rockville, Maryland 20855
1 Insert name of individual
------------------------
SUBCHAPTER
SECTION 305 MEETING
PURPOSE
This guide summarizes the administration authority, policies, and procedures
pertaining to an opportunity for presentation of views held in accordance
with Section 305 of the Federal Food, Drug, and Cosmetic Act.
AUTHORITY
The Department of Health and Human Services delegates broad authority
to the Commissioner of Food and Drugs under 21 CFR 5.1. The Commissioner's
authority for various activities is then redelegated under 21 CFR 5.30(a)
which reads in part:
The Directors and Deputy Directors of Bureaus, Regional Food and Drug
Directors, Deputy Regional Food and Drug Directors and District Directors
are authorized to designate officials to hold opportunities for presentation
of views which relate to their assigned functions under section 305 xxx
of the Federal Food, Drug and Cosmetic Act xxx."
PREPARATION
Except in unusual circumstances, the Compliance Officer who holds the
meeting will be the individual who issues the Section 305 Notice. As there
is normally a time lapse between the issuance of the Section 305 Notice
and the meeting date, the case should be reviewed immediately prior to
the meeting. The Compliance Officer should be completely familiar with
the charges, the law and regulations relating to them, and fully understand
the analytical methodology, if necessary, through discussion with the microbiologist
or chemist who performed the analysis.
Copies of the Act, regulations, official compendia, etc. should be assembled
for reference, if needed. In addition, pertinent information in the files
should be either marked for easy reference or photocopied to avoid searches
for data during the meeting. Such information may include records relating
to samples, EIR's, and FD-483, and documents relating to prior warnings
to the firm or individuals in the form of citations, seizures, prosecutions,
office interviews, letters, etc. To avoid the need to reread all of the
material, it is best to organize this material at the time of the initial
review when the Section 305 Notice is being prepared.
ATTITUDE OF COMPLIANCE OFFICER
The manner in which the Compliance Officer conducts the meeting and
his/her general demeanor in discussions with respondents throughout the
meeting are important for accomplishment of the purpose of the proceeding.
The Compliance Officer's attitude should be courteous and attentive. This
will facilitate a fair, frank and open discussion.
Many respondents have traveled long distances for a meeting. In their
effort to avoid late arrival they sometimes arrive early. When this happens
courtesy and good business operations require that the meeting be started
ahead of schedule whenever possible. Ensure that respondents awaiting the
start of a meeting are not allowed to wait in areas where regular business
is being conducted.
Respondents are occasionally quite upset due to the receipt of the Section
305 Notice and may tend to be discourteous or argumentative. The 305 meeting
is not a debate and nothing can be gained by the Compliance Officer losing
objectivity or by the respondent becoming abusive. The Compliance Officer
should politely point out that the proceedings are not a trial but rather
an opportunity for the respondents to give their side of the story and
discuss any mitigating circumstances, corrective actions taken or planned,
etc. Any information furnished will be considered by the FDA in its decision
regarding whether or not to forward the case to the Justice Department
for the institution of criminal proceedings.
RESPONDENTS' REQUEST FOR SPECIAL INFORMATION
On misbranding violations, respondents may submit proposed label revisions
during the meeting and request that the Compliance Officer comment on their
adequacy. Unless specific instructions have been provided from headquarters,
defer comment and explain that comments cannot be furnished until the label
is reviewed in detail by headquarters. Advise the respondents that the
proposed label revisions will be attached to the record as an exhibit.
If a respondent requests comment regarding proposed labeling revisions
for articles which are not the subject of the meeting, he should be advised
that they will be discussed as a separate matter after the Record has been
dictated.
Attorneys or respondents occasionally attempt to obtain detailed information
concerning the government's case. Such requests constitute requests for
information under the Freedom of Information Act. Under the Freedom of
Information Act, field personnel do not have the authority to deny requests,
and this should be pointed out to the attorney or respondent involved.
Respondents and their representatives should be advised that their requests
should be submitted in writing and will be forwarded to the Public Records
and Documents Center for consideration. To avoid misleading the attendees,
they should be advised that they probably will not receive records relating
to law enforcement actions which are exempt from disclosure (21 CFR 20.61
and/or 20.64).
NOTE: 702(b) portions of samples are always available to proposed defendants.
If a request is made for 702(b) portions of samples during a meeting, the
request should be honored. A signed receipt must be obtained for the sample.
DOCUMENTS WHICH MAY BE DISCLOSED
The following documents are available under the Freedom of Information
Act and FDA regulations. Requests for such documents during a 305 meeting
should be honored at the meeting. The district FOI officer should be consulted
concerning the redaction of releasable documents.
1. Published agency tolerances.
2. Copies of earlier EIR's and C/R's, laboratory reports, etc., which
are not part of the current file for potential criminal action.
3. Copies of any FD-482, FD-483, or FD-484 or any other documents already
issued to the firm even if they are connected with the case in question.
4. Laboratory worksheets applicable to the Section 305 Notice.
DOCUMENTS WHICH MAY NOT BE DISCLOSED
1. Unpublished tolerances or guidelines.
2. Copies of reports or memoranda connected with the case in question
(except worksheets).
CONDUCTING THE 305 MEETING
The Compliance Officer should strive for continuity and relevancy. Some
respondents are inclined to digress into time-consuming, irrelevant or
repetitious discussion unless there is a diplomatic effort to focus upon
relevant matters. A suggested routine format for achieving orderly progress
during the meeting is as follows:
IDENTIFICATION OF RESPONDENTS
After the respondents have been introduced and seated, make notes showing
the name, address, position, and business connection of each respondent.
The notes are for ready reference during the meeting and useful during
the dictation of the Record.
FAILURE OF RESPONDENT TO APPEAR
Frequently a cited individual does not attend the meeting. Determine
if anyone present purports to represent such respondent and enter any responses
into the record.
Designated representative(s) must have a signed written statement of
authorization for each respondent for whom he/she has authority to act.
If a representative appears without written authorization, the meeting
may proceed with respect to any respondent for whom the representative
appears, only if the Compliance Officer first verifies by telephone, or
other appropriate means, the authenticity of the representative (21 CFR
7.84(g)).
ATTENDANCE BY INDIVIDUALS NOT CITED
Occasionally an individual not included in the Section 305 Notice will
appear and during the course of the meeting it may become apparent that
person shares the responsibility for the violation and should have been
named. In such instances, request a short delay and have the legal clerk
prepare a supplemental Section 305 Notice including the individual's name,
present it to him, and proceed with the meeting.
Respondents may arrive at a meeting accompanied by many adherents. When
this situation occurs, the Compliance Officer should have each person identified
by name and relationship to respondent and obtain a statement on the record
that each is there on behalf of the respondent. The Compliance Officer
should then announce to the group that the meeting is not an open proceeding,
that it concerns only the respondent, and the only legitimate business
the other persons have in being there is that they are there on behalf
of the respondent; otherwise they may not be present. All persons remaining
present should then be heard. Unless this is done the respondent may claim
that he/she has been deprived of his/her rights to fully respond and explain.
MORE THAN ONE RESPONDENT
Requests for separate meetings should be in writing and should be received
at least three days before the scheduled date (21 CFR 7.84(e)). However,
if there is more than one respondent, advise the respondents in advance
that they are entitled to separate meetings if they so wish.
LEGAL STATUS SHEET, FD-454
Ask for the Legal Status Sheet. If necessary, the respondent may complete
the sheet before or at the meeting. Since there is no legal requirement
that it be furnished however, you may not demand that the sheet be filled
out or submitted.
EXPLAIN THE PURPOSE OF THE MEETING AND THE CHARGES
Although the Form FD-466a, which accompanies the Section 305 Notice
and Charge Sheet, contains information concerning the reason for the notice,
its purpose should be reiterated prior to the discussion of the charges.
The respondents should be advised that the meeting is being held in accordance
with section 305 of the FD&C Act in order to give them an opportunity
to present any facts they believe are relevant prior to the FDA making
its decision whether to recommend prosecution to the Justice Department.
They should be advised that the purpose is not to resolve conclusively
whether violations occurred, and therefore FDA will not present either
witnesses or evidence at the meeting. The Compliance Officer should briefly
state the information in the FDA's possession which indicates that violations
of the FD&C Act (and other laws, if pertinent) have occurred and that
the individuals listed in the Section 305 Notice were responsible, either
through their actions or failure to take action. This may be by reference
to the pertinent inspections, FD-483s, regulatory letters etc., i.e. a
basic reference to relevant time and acts. Request that the respondents
follow their copies of the Section 305 Notice and Charge Sheet as the Compliance
Officer either reads verbatim or summarizes the pertinent information concerning
the shipment or receipt of each product and the charges pertaining to it,
or the acts which constitute violations.
The Compliance Officer should inquire if the respondents understand
the charges. If the response is negative, any questions should be answered
to assure that the basis of the allegations is understood. If the respondents
indicate that the shipping or receiving dates are incorrect, the discrepancies
should be clarified. If they indicate that they will make no admissions
with regard to the shipment or receipt of the products, do not pursue the
matter.
MIRANDA WARNING
The question has been raised in the past regarding whether the Compliance
Officer needs to give the "Miranda Warnings" prior to conducting
a meeting. They should not be given.
In Miranda v. Arizona, the court ruled that when an individual is taken
into custody or otherwise deprived of his freedom and is subjected to questioning,
the person must be notified of his right to remain silent, that anything
he says may be used against him, and that he has the right to an attorney.
This warning does not apply to Section 305 meetings because a respondent
to a Section 305 Notice is not "taken into custody or otherwise deprived
of his freedom." In addition, even though not required, the respondents
are notified (Form FD-466a) that they are not compelled to answer and that
they may be represented by an attorney. In 1976, in Beckwith v. United
States, the Supreme Court held that even when the investigation has "focused"
on an individual, he is not entitled to Miranda warnings unless he is in
custody. In Oregon V. Mathiason, decided in January, 1977, the Supreme
Court held that a meeting at which the individual was free to leave did
not require Miranda warnings.
RESPONDENTS' STATEMENT
After discussing the purpose for the meeting and the charges, the respondents
should be invited to state their views with respect to the alleged violations.
Take notes regarding the various points covered by the respondents to assure
that pertinent comments are not inadvertently omitted when the summary
is dictated.
Occasionally respondents appearing at a meeting present a prepared written
response. In such instances, the Compliance Officer should, if practical,
read the written response aloud while the respondents follow their copies.
The Compliance Officer should ask questions regarding any points which
need clarification. In the dictation of the summary of the meeting, refer
to the written response, which will be attached to the record as an exhibit,
indicate that it was read aloud in the presence of the respondents, and
include in the dictation only information concerning the points discussed
for clarification.
Each respondent may present any information bearing upon the issues.
This may consist of letters, laboratory data, sanitation contracts, etc.
Identify each exhibit submitted by respondents at a meeting with the related
sample number, date received, and the Compliance Officer's initials. Place
the identification at the top right hand corner of the exhibit if possible
to do so without obscuring any material.
ASSURE SCOPE OF RESPONDENTS' RESPONSIBILITY
Usually respondents demonstrate their responsibilities while expressing
their views with respect to the alleged violations. This normally is expressed
in the form of comments such as "I hired extra men for sanitation"
or "I ordered the destruction of the merchandise" etc.
If there are any doubts about the responsibility of any of the respondents,
questions should be asked to assure that individuals who lack the authority
to detect, prevent or correct violations are not included in a criminal
proceeding. Examples of the types of questions which may be necessary are
those which determine who had the authority to change pest control firms
or consulting laboratories, who hires or discharges employees for sanitation
or quality control work, who directs labeling changes, who expends monies
for structural repairs and the purchase of new equipment, etc.
In addition to the responsibility of those who appear, it may be necessary
to make inquiries regarding the responsibilities of an individual listed
in the Section 305 Notice who does not appear. This could be particularly
important in cases where officials of a company at a location other than
the one inspected are cited, but do not appear at the meeting.
GUARANTEES
Unless a respondent voluntarily includes as part of his presentation
a guarantee related to the violations, explore thoroughly the question
of whether one exists. Otherwise, the respondent may overlook the fact
that he had a guarantee, until he or his attorney eventually presents it
as a defense at trial.
If a respondent requests information regarding guarantees so that he
may obtain them in the future, furnish a copy of 21 CFR 7.13.
If the respondent presents a guarantee at the meeting, do not comment
upon its validity. Guarantees presented at meetings seldom follow closely
the form specified in the CFR. Tell the respondents that the validity of
the guarantee will be reviewed after the meeting.
SUMMARY
At the conclusion of the meeting, the Compliance Officer will dictate
an accurate summary of the meeting in the presence of the respondents,
or at their option, immediately after their departure. The respondents,
for a variety of reasons, may desire early departure from the meeting and
should be afforded that option. In that event, a draft copy of the summary
should be forwarded to the respondents requesting their comments within
10 days and explaining that without benefit of comment the record will
stand as drafted. In the event respondents remain during the dictation,
they should be offered an opportunity to provide additional comments or
corrections. The statement may be dictated to a stenographer, or into a
recording device. Inform the respondents that if they disagree with, or
wish to clarify, any of the statements they may do so after the summary
is dictated.
If respondents undertake to have long or irrelevant statements included
in the dictated summary suggest tactfully that a statement may be submitted
subsequently and will be attached to the Record (21 CFR 7.85(g).
Required Statements
The Summary should always contain statements to the effect that:
1. The purpose of the meeting was discussed with the respondents and
they understood that it was being held pursuant to Section 305 of the Act.
2. The charges were discussed with the respondents and they understood
them.
3. The respondents indicated that the shipments had been made, or received,
as alleged. (If not admitted, or they have reservations, this information
should be included).
4. Information concerning the statements each respondent made concerning
his scope of authority (responsibility) at the firm.
5. The respondents were asked if they had any corrections or comments
to make (followed by their statements or a comment in the record that they
had none).
6. Copies of the Summary will be forwarded to the respondents.
7. The final section of the record should consist of a statement indicating
that the Summary was dictated in the presence of the respondents and when
asked if they felt that the dictation accurately and fairly summarized
the discussion they indicated that it did (or did not in the following
respect). If the respondents elected not to remain during the dictation
of the summary, the final section of the draft should reflect that fact.
The copy of the typed summary which is provided to each respondent should
be accompanied by a cover letter which states that the firm and individuals
have been given an opportunity to make any additions or corrections in
writing within 10 days after receipt.
Addendum to the Summary
Occasionally after the respondents have left the premises, the Compliance
Officer will realize that significant information was omitted from the
Summary. In such a case, an addendum to the Summary should be dictated
and mailed to the respondents along with the Summary dictated in their
presence. A cover letter should accompany the Summary and addendum pointing
out the inadvertent omission. Request a letter from the respondents within
10 days indicating that the additional information had been discussed as
recorded in the addendum.
A respondent may request that the meeting be reopened in order to submit
new information for the record. Such a request must be timely, in writing,
state the nature of the new information, the reason it was not previously
available at the time of the original meeting and why the information cannot
be submitted in documentary form. If the District concludes that the meeting
should be reopened to receive the new information, it may do so.
Following the meeting respondents will, on occasion, request an additional
meeting at headquarters to discuss the matter further. Such meetings will
be considered an extension of the Section 305 meeting and will be governed
by the procedures of this chapter.
Verbatim Transcript of Meeting
The respondent has the right to a verbatim transcript, at his expense.
If this right is exercised, the respondent must provide the necessary person
or equipment to make the transcript. A copy of such transcription must
be submitted by the respondent to the District at no cost with an opportunity
to make corrections and obtain agreement as to its accuracy. Under these
circumstances, the Compliance Officer need dictate only a brief in-house
summary after departure of the respondents, explaining the circumstances
under which the verbatim transcript was made, who was present, etc. No
"Summary" should be prepared.
The Compliance Officer may also order the meeting transcribed at FDA's
expense, a copy of the transcription to be provided to each respondent
(21 CFR 7.85(e)).
Handling of Stenographer's Notes or Electronic Recording
The stenographer will use a separate notebook for taking the statement
dictated by the Compliance Officer or for verbatim notes. Use only one
side of the sheet and number the pages consecutively for each meeting.
Identify the notes with date of meeting, name of firm cited, sample numbers
and stenographers's name. After the pages have been transcribed, remove
from notebook and file in the lead sample jacket of the case. Hold until
the 10 day period for review by the respondent has expired, then remove
and destroy.
If the meeting statement has been recorded on dictating equipment, after
transcribing insert the belt or tape in a plain envelope mounted on Kraft
paper. Identify the envelope with date of meeting, name of firm cited,
sample numbers, and transcriber's name. File in lead sample jacket and
retain until the 10 day period for review by the citee has expired, then
remove and destroy, or erase.
Preparation of Summary
Number of Copies - Prepare the Summary as a separate statement.
Make sufficient copies for the following distribution:
Original + 1 copy for Center
(hold for submission with case)
One copy for HFA-224
One copy for District lead sample file
One copy for District establishment file on firm
One copy for Resident Investigator, if desired
One copy for District reading file
One copy for each respondent
Method of Preparation - Use white bond original, white manifold
for respondent's copy, and white and/or colored manifold for remaining
copies in accordance with District custom. It is suggested that the copy
filed in the EI folder be prepared on distinctively colored paper for ready
identification. Follow the format in the exhibits. On the copy to each
respondent, add the following statement at the bottom of the report.
"Copy of this Summary (or transcript) furnished to (respondent).
Include the transmittal letter advising of 10 days for additions or
corrections.
MULTI-SESSION MEETINGS
The regulations are intended to limit multi-session meetings. Requests
for changes in time and place of the meeting must be made in accordance
with 7.84(e). New evidence may be submitted in accordance with 7.85(g).
Nevertheless, a respondent may appear for a meeting, but claim he has further
evidence to submit. If the request is reasonable, recess the meeting until
a mutually agreeable date. Prepare only one Record covering both meetings.
When the respondent merely requests an opportunity to submit supplemental
documentary evidence without further personal appearance, he may do so
within ten days as provided in 7.85(g). Additional information and/or documentation
should be marked as an exhibit and added to the Record.
RESPONSE BY MAIL
Frequently, respondents elect to make response in writing in lieu of
personal appearance. It is not necessary to acknowledge receipt of such
response. However, acknowledgements may be desirable to clarify some point
of misunderstanding or oversight on the part of the citee.
Correspondence should be held to a minimum lest the episode resembles
"holding a meeting by mail."
PROCEDURES AFTER MEETING
After the meeting (or written response, if any) a decision must be made
as to disposition of the charges for each sample involved. The charges
are disposed of by one or a combination of the following actions:
Permanent Abeyance
Temporary Abeyance
Prosecution
REPORTING PA & TA CASES
Cases which are placed in abeyance should be processed in the District
within seven days after the meeting, with notification to the Administration
as described below.
Permanent Abeyance
Prepare a memorandum to the appropriate Center(s) compliance office,
headed "PA after CITATION" which provides the reason for placing
the case in PA and the planned District follow-up. Attachments should include
a copy of the Section 305 Notice endorsed "PA (date and initials)",
a copy of the Charge Sheet, a copy of the Summary and relevant information.
Copies of all the above documents should be held in the District case file.
A copy of the memorandum to the Center(s), an endorsed "PA (date
and initials)" copy of the Section 305 Notice, and a copy of the Charge
Sheet should be forwarded to the district establishment file and to the
Regulatory Records Unit (HFA-224).
The Sample Accountability Records (orange copy) should be held in the
Home District's Compliance Branch for 60 days beyond the date of PA conclusion
before issuance.
Temporary Abeyance
Prepare assignments for necessary follow-up and forward copies to the
appropriate Center(s) Compliance office. Hold the file and Sample Accountability
Record in the District Compliance Branch. Send a copy of the Charge Sheet
and Section 305 Notice endorsed "TA (date and initials)" to Regulatory
Records Unit. A case in TA is not considered closed.
NOTIFICATION OF NON-PROSECUTION
When it has been finally determined by the agency that none of the individuals
will be recommended for prosecution, (case is closed) the district that
issued the 305 Notice will advise them in writing of that fact (21 CFR
7.85(h)(1)).
After the Agency has made a decision to decline prosecution, that decision
must be communicated to the office that originated the prosecution recommendation
(generally a District Office ) to assure notification of non-prosecution
issues in accordance with regulations. The FDA unit to which the recommendation
was made, e.g., Center, OE, GC, is responsible for issuance of the declination
to the originating office/District. Upon receipt of the declination, and
absent a request for reconsideration of the recommendation, the originating
office/District should issue the notification of non-prosecution within
10 working days.
When one of several cited persons will not be included, the Office of
General Counsel will determine when that person shall be notified (21 CFR
7.85(h)(2)). General Counsel will notify the district of this fact, and
the district will issue the letter. The latter procedure applies when the
Department of Justice declines to proceed with the entire case (21 CFR
7.85(h)(3)) or declines to proceed against an individual (21 CFR 7.85(h)(4)).
See Exhibit 5-12 for model letter to be used.
EXHIBITS
5-11 Summary Format - Section 305 Meeting
5-12 Notification of Non-Prosecution
CHAPTER 5 - EXHIBITS
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