CHAPTER 9

IMPORT OPERATIONS/ACTION

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CONTENTS

SUBCHAPTER - IMPORT PROCEDURES

Purpose ...............................................................338
Scope..................................................................338
Division of Authority..................................................338
Delivery Under Bond....................................................339
Sampling...............................................................339
Mail...................................................................340
Payment for Samples....................................................340
Notice of Sampling.....................................................340
Procedure Regarding Warehouse Entries   
Procedure when no Violation is Found...................................341
Procedure when Samples cannot be Examined..............................341
Procedure when Violation is Found......................................341
Inspection after Completion of Authorization to Bring Article Into
    Compliance.........................................................342
Procedure when Conditions of Authorization have been Fulfilled.........342
Procedure when Conditions of Authorization have not been Fulfilled.....342
Payment of Costs of Supervision of Relabeling and/or Other Action......342
Exportation of Merchandise Refused Admission...........................343
Shipment to Other Ports................................................343
Bond Action............................................................343

SUBCHAPTER - RELEASE NOTICES

Purpose................................................................344
Background.............................................................344
General Comments.......................................................344
"Straight" Release.....................................................344
Release without Examination............................................344
Release with Comments..................................................344
Release after Detention................................................345
Exhibits...............................................................345

SUBCHAPTER - AUTOMATIC DETENTIONS

Purpose ..............................................................345
Authority and Background..............................................346
Procedural Guidance...................................................346
Recommendations Involving Pesticides Residues ........................346
Direct Reference Authority Recommendations ...........................346
Recommendations Based on  EIR's, Other Government Agencies, 
      MOU's etc.......................................................347
DIOP Responsibilities   ..............................................347
Automatic Detention Recommendations ..................................347
Recommendations Based on One Violative Sample.........................347
Recommendations Based on Information and Historical Data  ............348
Recommendation Based on Multiple Samples .............................348
Automatic Detention of Importer's Entries ............................349
Recommendation Based on Establishment Inspection......................349
Other Situations......................................................349
Party Notification of Automatic Detention Decision....................350
Removal from Automatic Detention......................................350
Removal of Products/Manufacturers/Countries Except Fresh Produce......352
Removal of Importers..................................................352
Removal Based Upon an Establishment Inspection .......................353
Notification of Removal From  Automatic Detention  ...................353

SUBCHAPTER - NOTICE OF DETENTION AND HEARING

Purpose ..............................................................353
Definition............................................................353
Guidance..............................................................353
Custody over Detained Shipments ......................................354
Specimen Charges......................................................354

SUBCHAPTER - RESPONSE (HEARING) TO NOTICE OF
DETENTION AND HEARING

Purpose ..............................................................354
Background............................................................354
Eligibility of Respondents............................................354
Scheduling Hearing & Postponements....................................355
Conduct of Hearing....................................................355
Replies by Mail ......................................................356

SUBCHAPTER - NOTICE OF REFUSAL OF ADMISSION

Purpose ..............................................................356
Background............................................................356
Guidance..............................................................356

SUBCHAPTER - RECONDITIONING

Purpose ..............................................................358
Background............................................................358
Who May File an Application ..........................................358
Mechanics in ProcessingApplication ...................................358
Amended Applications..................................................359
Requests for Additional Time  to Complete Reconditioning .............359
Unsuccessful Reconditioning of Adulterated Merchandise ...............359
Disposition of Lots not Reconditioned to FDA Satisfaction.............360
Reconditioning Operations.............................................360
Exhibits..............................................................361

SUBCHAPTER - SUPERVISORY CHARGES

Purpose ..............................................................361
Background............................................................361
Supervisory Charges...................................................361
Preparation & Submission of Charge Sheet    ..........................362
Payment of Supervisory Charges .......................................362

SUBCHAPTER - BOND ACTIONS

Purpose ..............................................................362
Background............................................................362
Bond Violation........................................................362
Bond Action Procedure.................................................363
Responsibility under the Bond.........................................364
Penalty Recommendation ...............................................364
Tracking of Penalty Actions...........................................364

SUBCHAPTER - IMPORT INFORMATION DIRECTIVES

Purpose ..............................................................364
Background............................................................365
Approach..............................................................365
Import Alerts.........................................................365
Import Bulletins .....................................................366

SUBCHAPTER - PRIORITY ENFORCEMENT STRATEGY FOR
PROBLEM IMPORTERS

Purpose ..............................................................366
Background............................................................366
Approach..............................................................367

EXHIIBITS

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SUBCHAPTER

IMPORT PROCEDURES

PURPOSE

The FDA Operational Import Procedures outline the basic procedures and responsibilities of the Food and Drug Administration and the U.S. Customs Service in the enforcement of the Acts listed under SCOPE as they apply to amenable imported articles.

SCOPE

The procedures outlined in this document cover imported merchandise subject to, but not limited to, the following Acts:

DIVISION OF AUTHORITY

The Food and Drug Administration, through the Regional Food and Drug Director, District Director, or his authorized representative, determines whether or not an article is in compliance with or in violation of the provisions listed in the Acts. FDA District also determines whether or not the article may be brought into compliance with the appropriate statute and, at the FDA's discretion, authorizes reconditioning for that purpose.

Supervision over the fulfillment of the conditions of the authorization when granted is exercised by either FDA or Customs as mutually arranged. At ports in reasonably close proximity to a Food and Drug Administration office, such supervision is ordinarily exercised by FDA. At far distant ports such supervision is ordinarily exercised by Customs.

The refusal of admission, exportation, and destruction of merchandise in violation of the Federal Food, Drug, and Cosmetic Act and of other Acts enforced by FDA are carried out under the direction of U.S. Customs. (However, at some ports the actual supervision of the destruction of violative merchandise is conducted by the Food and Drug Administration pursuant to a local FDA/Customs agreement).

DELIVERY UNDER BOND

Formal Entries

No food, drug, device, biologic, cosmetic, radiation emitting device, or other article subject to the Acts enforced by FDA is to be delivered to the importer or consignee, prior to report of examination of the article or prior to the stamping of entry documents as set forth in this paragraph, indicating that no sample is desired, except upon the execution on the appropriate form of a Customs single entry or term bond in good and sufficient sum, containing a condition for the redelivery of the merchandise or any part of it upon demand of U.S. Customs at any time as prescribed for such bonds in the Custom's regulations in force on the date of entry. The bond is filed with U.S. Customs which, in case of default, takes appropriate action to effect the collection of liquidated damages provided for in the bond after consultation with FDA. [19 U.S.C. Section 113.62(k) and 21 CFR Section 1.97]

Notification of the Customers entry is generally accomplished by electronic submission of information through the U.S. Customs Automated Commercial System (ACS). For entries requiring further examination, FDA will be provided with the appropriate U.S. Customs Service Entry Summary or other entry documents with a copy of the invoice, etc. For those occasions when an entry is not filed electronically, the same procedure for submitting entry documents will be followed as noted for further examination of electronic entries. Note: the FD 700 set (Importers Entry Notice) and FD 720 set (Land Port Entry Notice) are no longer used for FDA notification.

Informal Entries

Normally, informal entries (value less than $250) do not require posting a redelivery bond. When a shipment in this category is to be sampled, make a request to U.S. Customs for the filing of a formal entry, if there is reason to believe that the shipment will not be held.

The FDA (District Office) shall receive notification of all informal entries of merchandise subject to its jurisdiction lodged at ports of entry located in its territory. The means of getting notification can be arranged through local U.S. Customs/FDA District agreements. However, the most satisfactory means of getting notification would be as specified under "Formal Entries," above.

SAMPLING

Ports Covered by FDA

Both formal entries (value over $1250) and informal entries (value under $1250) are offered for import at seaports, airports, overnight carrier hubs, border crossings, and as personal baggage. When an entry is filed with the U.S. Customs Service, it will first be screened by the Customs Service Automated Commercial System (ACS) to determine if the article is subject to FDA jurisdiction. The ACS screening provides the filer with several options for the entry. If the article is not subject to FDA jurisdiction no Other Government Agency (OGA) flag for FDA will appear. If the article may be subject to FDA jurisdiction, which would be determined by the intended use of the product, a FDA flag of FD1 will appear. The filer would then, based on intended use either submit FDA information for the product if subject to FDA, or use a "Disclaimed" notification to Customers to indicate it is not subject to FDA review. Entries receiving a ACS flag FD2 must submit information on the article to FDA. For a limited number of articles which are subject to FDA jurisdiction, but for various reasons FDA has determined we do not require notification, a flag of FDO will appear on the Customs screen. This will allow Customs to proceed clearing the entry without any further FDA notification. Once the filer is notified FDA review is required, the filer will provide appropriate copies of all import documents (Customs Entry Summary or equivalent, commercial invoice or equivalent, and any other necessary documentation to the FDA office responsible for the review of the entry. A determination will then be made as to what type of coverage will be made. Note: the use of the FD-700 set (Importer Entry Notice) and the FD-720 set (Land Port Entry Notice) are no longer used by FDA district offices. Any notification of an entry to FDA offices will use appropriate U.S. Custom's forms with attachments of the importing documents.

After the entry has been evaluated in the ACS system and meets requirements for further FDA review, the filer is required to provide FDA with the FDA data elements which are entered through the Customs ACS and used the FDA Electronic Entry Processing System (EEPS) to determine what action FDA will take regarding the entry. If a sample is desired, the filer will be provided with appropriate notification, either a Notice of Sampling or other local form of notification, from the FDA office, that the entry is to be held for FDA examination or sampling at a designated location when the article is available. Generally when a sample is desired, FDA, acting upon authority delegated to it by U.S. Customs, will collect the sample for examination.

As the end of 1995, all U.S. Customs ports of entry using the ACS electronic filing system will be able to provide notification of an entry to any FDA district office. Therefore, at remote port location where FDA does not maintain and office, the entry information will be transmitted through the ACS electronic system to be designated FDA office, for review and decision.

Ports not Covered by FDA

For those few ports where U.S. Customs does not maintain its ACS electronic entry process, and FDA does not generally cover the port under its normal operating schedule, the responsible FDA district office will coordinate coverage with the responsible Customs Port Director for assuring FDA of appropriate notification. If FDA should desire to examine or sample articles being entered through such a port, appropriate communications with the U.S. Customs office, importer and/or broker will be made to notify the importer of FDA's desire.

Generally, for these type of entries, examination and/or sampling will take place at the designated location for unloading. Under certain conditions, however, FDA may ask Customs to collect a sample at the point of entry for forwarding to the FDA district laboratory. Appropriate information on the entry, sample, and requirements for holding the entry will be provided to the Customs officials and importer by the responsible district.

If no sample is desired, the FDA should immediately advise U.S. Customs to that effect. Such advice is equivalent to a "May Proceed Notice" at ports where Districts are located indicating that the shipment may proceed without FDA examination.

If a sample is desired, FDA should immediately request Customs to forward it, indicating the size of the sample desired. U.S. Customs should forward the sample without delay, together with a description of the sample and shipment on the applicable FD form.

In order to facilitate the handling of shipments offered for import, FDA may periodically furnish to Customs a list of articles, samples of which are desired when offered for import. Customs should send such samples to FDA without delay together with a description of the sample and shipment on the applicable FD form.

Local FDA districts should consider holding training sessions for U.S. Customs inspectors if they are collecting samples for FDA. These sessions should include the aspects of sample size, method of collection, sample identification, shipping, completion of FDA forms, etc.

MAIL

In the case of imports by mail, FDA Districts should develop a procedure for coverage of mail through district arrangements made with the local Customs office. Include in the procedure such information as to who is responsible for mail coverage, when (how often), etc. See RPM Chapter 9-71 for more specific guidance on coverage of importations by mail.

PAYMENT FOR SAMPLES

The Food and Drug Administration will pay for all samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act and as provided for under the regulations promulgated under the other Acts it enforces. Billing for reimbursement shall be made by the owner or consignee to the Food and Drug District Office in whose territory the shipment was offered for import. Do not pay for samples if the article is found to be in violation even though the shipment is "Released with Comment." Do not pay for samples taken in connection with the supervision of fulfillment of the conditions of an Application to Relabel or Do Other Action. (Reconditioning Application). Payment shall be made for samples collected as an audit of a private laboratory analysis if it is found in compliance (this is not a reconducting audit sample).

NOTICE OF SAMPLING

Whenever a sample is taken by FDA, a Notice of Sampling over the signature of the District Director of Customs or an authorized facsimile of it; or by signature of the FDA employee if written authority for this duty has been received from the District Director of Customs. Send a copy to Customs for their files as determined by local agreement with Customs. If Customs collects the sample they should mail the Notice of Sampling to the owner or consignee.

PROCEDURE REGARDING WAREHOUSE ENTRIES

Purpose

To provide districts with guidance regarding submission of entry notification to FDA by Customs for importers filing warehouse entries.

Background

When a product is imported into the United States, the Importer of Record (Importer) must file entry paperwork with the U.S. Customs Service (Customs). The importer may choose to file a consumption entry, pay any applicable duty, and introduce the product into domestic commerce. Alternatively, the importer may file a warehouse entry, store the product in a bonded warehouse for up to five years, and pay duty only when the product is withdrawn for domestic commerce (withdrawal for consumption). If the importer exports the product while it is under bond, no duty is incurred.

There have been several instances where importers have questioned FDA's authority over, or right to see paperwork for, FDA regulated product covered by warehouse entries and intended for later export rather than domestic consumption.

Any product brought into the United States from a foreign country is "imported" and, therefore, subject to the import provisions set forth in section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA). Thus, all importers, including those filing warehouse entries, are subject to section 801 procedures, regardless of whether the intent is to later export the imported products. See also Compliance Policy Guide 7150.11 (Sec. 110.200), "Export of FDA Regulated Products From U.S. Foreign Trade Zones."

Guidance

To fulfill its obligation to ensure that regulated products comply with the requirements of the FFDCA, FDA should receive notification either electronically or by paper, no later than the time the warehouse entry is filed with Customs.

PROCEDURE WHEN NO VIOLATION IS FOUND

If the shipment is found to be in compliance after examination, notify the owner or consignee using the appropriate Release Notice or computer generated notice or other appropriate forms that the shipment may be admitted insofar as FDA is concerned. Send a copy of the Release Notice to Customs. (See RPM page 344 for detailed guidance.)

PROCEDURE WHEN SAMPLES CANNOT BE EXAMINED

Under certain circumstances, samples for which a Notice of Sampling has been issued cannot be examined. In these cases, "stamp off" the shipment using the regular Release Notice amended as follows:

"May proceed without FDA examination on responsibility of the importer."

Also use this procedure for those lines of an entry where a Notice of Sampling was issued for the entire entry but where all the lines are not sampled or examined by adding to the amended Notice "Lines not sampled." Send a copy to Customs if they so require.

PROCEDURE WHEN VIOLATION IS FOUND

Preliminary Notice - "Notice of Detention & Hearing"

If examination of the sample or other evidence indicates that the article appears to be in violation and detention is the course of action, notify the owner or consignee using the computer generated or other accepted (Notice of Detention and Hearing) form. Specify on the notice the nature of the violation charged and set a place at which the owner or consignee provide testimony as to the admissibility of the article. FDA has determined a ten day time period is preprinted on the form as the time during which this evidence may be offered. However, if for some compelling reason it is felt ten days is insufficient, such as inordinate mail delays, this time period may be extended to be more reasonable. Send a copy of this Notice to Customs. (See RPM page 353 for detailed guidance.)

Hearing - "Request for Authorization to Relabel or

Perform Other Acts"

At the hearing or through other response the importer may present evidence as to the admissibility of the article and the manner in which the article can be brought into compliance with the appropriate Act or (in the case of a food, drug, device, or cosmetic) be removed from jurisdiction of the Federal Food, Drug, and Cosmetic Act. Upon the timely submission of Form FD-766 (Application to Relabel or Perform Other Action) and the execution of a good and sufficient bond by the owner or consignee, FDA may authorize relabeling or other action. After consideration of the application, indicate approval or disapproval of the application, and if approved the conditions to be fulfilled and the time limit within which to fulfill them. Send original to the applicant with a copy to Customs, and retain a copy in district files. (See RPM page 354 for guidance on hearings and RPM page 358 on reconditioning.)

The redelivery bond on file with the District Director of Customs for the particular importation applies to any relabeling or other action authorized, and a new bond will not have to be filed.

Procedure after hearing - "Notice of Release"

If after the hearing it is determined that the article should not be refused admission, notify the owner or consignee by computer generated or other appropriate (Release Notice) that the detained shipment may be admitted insofar as the FDA is concerned. Caption this Release Notice "Originally Detained and Now Released" and if indicated explain the reason for the change of action. Send a copy to Customs. (See RPM page 344 for detailed guidance.)

Procedure after hearing - "Refusal of Admission"

If after consideration of all evidence it is decided that the shipment appears to be in violation, notify the owner or consignee over a facsimile of the signature of the District Director of Customs on computer generated or other appropriate Notice of Refusal of Admission that the shipment is refused admission. On this document state the charges exactly as shown on the original (or amended) Notice of Detention. Send a copy to Customs. See RPM page 356 for detailed guidance.) This document provides for the exportation or destruction of the shipment under Customs supervision within 90 days of the date of the notice, or within such additional time as specified by U.S. Customs. The FDA files should remain open until the return copy is received from Customs indicating that the merchandise was either destroyed or exported. FDA should not close its files until final disposition has been determined because we are responsible for the protection of the U.S. public regarding foods, drugs, cosmetics, etc. and therefore that responsibility exists until the violative article is either destroyed or exported. Some districts have developed combination Notice of Refusal or Admission and Notice of Redelivery forms with their local Customs Offices. At this time use of the combined form has not been approved for national applications. Until the format of combined notices is authorized, districts should continue to follow local procedures as instituted.

Procedure after hearing - Permission to Recondition

If after the hearing the importer decides to attempt to bring the article into compliance with the Act or remove it from jurisdiction of the Act, and a timely submission of Form FD-766 is received, full consideration should be given the application as specified under "Hearing - Request for Authorization to Relabel or Perform Other Acts."

INSPECTION AFTER COMPLETION OF AUTHORIZATION TO BRING ARTICLE INTO COMPLIANCE

After the relabeling or reconditioning operations have been completed the applicant must execute and submit the "Importer's Certificate" on the reverse side of Form FD-766. At this point conduct the follow-up inspection and/or sampling to determine compliance with the terms of the authorization as deemed necessary and as district procedures require. This inspection and/or sampling may be made by an officer of FDA or Customs. The "Report of Inspector" on the reverse side of FD-766 shall be completed by the inspecting officer and forwarded to the appropriate FDA office.

PROCEDURE WHEN CONDITIONS OF AUTHORIZATION HAVE BEEN FULFILLED

If the conditions of the authorization have been fulfilled, notify the owner or consignee by computer generated or other authorized Release Notice that the admissible portion may be admitted insofar as FDA is concerned. Caption this notice "Originally Detained and Now Released". Send a copy of this release to Customs. The non-admissible portion (rejects) must be destroyed under U.S. Customs or FDA supervision in accordance with local agreements. A notice of refusal of admission should be issued for the rejected portion if it is to be re-exported under Customs supervision. Normally, non-admissible portions (rejects) of reconditioned shipments will not be permitted exportation.

PROCEDURE WHEN CONDITIONS OF AUTHORIZATION HAVE NOT BEEN FULFILLED

If the initial attempt at reconditioning is not successful, a request for authorization of a second reconditioning on Form FD-766 should not be considered unless it includes a change or adjustment from the original authorized method and the applicant can show reasonable assurance that the second attempt will be successful. If the conditions of the authorization have not been fulfilled, immediately issue a computer generated or other authorized Notice of Refusal of Admission to the owner or consignee. Send a copy of this notice to Customs.

PAYMENT OF COSTS OF SUPERVISION OF RELABELING AND/OR OTHER ACTION

Charges for the above will be in accordance with existing regulations. [21 CFR Section 1.99] (See RPM page 361 for detailed guidance on supervisory charges.)

U.S. Customs, upon receipt of the charges for supervision (Form FD-790), should add to it any expenses incurred by that agency in this action and send it to the owner or consignee. The expenses shall include charges of supervision of destruction of the article or rejects as provided for by the provisions of the Act of February 13, 1911, as amended (Section 5, 36 Stat. 901 as amended; 19 U.S.C. 267). The remittance by the owner or consignee shall be submitted to U.S. Customs.

EXPORTATION OF MERCHANDISE REFUSED ADMISSION

Exportation of merchandise refused admission into the United States is done under Custom's supervision in accordance with regulations which have been or may be prescribed by the Secretary of Treasury. However, if after a reasonable time, FDA has not received the return copy of the "Refusal Notice" showing final disposition of the shipment, the District should investigate the status of disposition. Districts should also consider under certain conditions verifying the refused goods have been held pending this re-exportation or destruction. Guidance on refusals to be verified may change based on the reason for detention. Districts should follow guidance issued to the field. (Also see previous Import Chapter 9-41.)

SHIPMENT TO OTHER PORTS

When imported merchandise subject to the provisions of Acts enforced by FDA is shipped from one port to another port for exportation, such shipment should be made under a Custom's carrier's manifest, Customs Form 7512, in the same manner as shipments in bond. When imported articles are being shipped for purposes of reconditioning, we should require that such movement be made only under U.S. Customs or FDA seal. Each District should also coordinate such movement with other districts when the merchandise is being shipped to locations in their district boundaries.

BOND ACTION

If Customs has evidence tending to show that the article or any portion of a shipment was disposed of in violation of the terms of the appropriate act or its regulations or of the terms of the bond, they should immediately send such evidence to FDA.

The District upon receiving such evidence shall immediately investigate the matter and send a detailed statement showing the importer's liability under the redelivery bond or other applicable customs bond to Customs. If the facts warrant, and the article was under detention, and the Notice of Refusal of Admission has not been issued, immediately issue a Notice of Refusal to the owner or consignee with a copy to Customs.

If FDA acquires evidence that the disposal of an article or any portion of a shipment was in violation of the terms of the appropriate act or its regulations or of the terms of the bond, immediately send to Customs a detailed statement showing the importer's liability under the redelivery bond or other applicable customs bond. Depending on the conditions, issue a form FD-712 (Notice of Refusal) if not already issued and the article had been detained or request U.S. Customs in writing to ask for redelivery of the merchandise if it has not been detained. If an FD-772 is issued send a copy to Customs.

Customs, within three days of the receipt of the statement and evidence, should notify the owner or consignee in writing that the article must be returned to their custody. The district offices should consider preparing this original letter for the signature of the District Director of Customs, and forward it to Customs along with the detailed statement described in the above paragraph. If the article is not returned to Customs custody within 30 days from the date of the notice, action should be taken immediately to enforce the terms of the bond, unless in the meantime the owner or consignee or his representative files with Customs an application for cancellation of the liability incurred under the bond upon the payment as liquidated damages of a lesser amount than the full amount of the liquidated damages incurred, or upon the basis of such other terms and conditions as the Secretary of the Treasury may deem sufficient. The application should contain a full statement of the reasons for the requested cancellation of liability and should be in duplicate and under oath.

Upon the receipt of an application for relief as provided above, Customs may cancel the liability for liquidated damages incurred under the bond upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but Customs may not act under the section in any case unless the FDA district having jurisdiction at the port of entry is in full agreement with the action. (See RPM page 362 for detailed guidance on bond actions.)

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SUBCHAPTER

RELEASE NOTICES

PURPOSE

To provide the field with procedural guidelines in releasing imported lots for which a Notice of Sampling has been issued.

BACKGROUND

The Federal Food, Drug, and Cosmetic Act, and it's regulations directs that a notice (Notice of Sampling) shall be given to the owner or consignee of imported merchandise sampled or intended to be sampled under the authority of the Act. The regulations also require the issuance of a further notice to advise the owner or consignee of the result of examination of the sample, for which a Notice of Sampling has been issued [21 CFR and 1.90]. The Release Notice advises the owner or consignee that the merchandise need not be further held insofar as the FDA is concerned.

GENERAL COMMENTS

Release Notice Form or computer generated notice from LISTS or OASIS, issued by FDA under the signature of the field compliance officer or designated individual authorized by the district to sign the notice, whenever FDA has no further interest in a lot for which a Notice of Sampling (Form FD-712 or computer generated notice from LISTS OR OASIS) has been issued.

The Release Notice is routinely issued to the importer of record with a copy to Customs and the FDA district fiscal office and file. In accordance with local practices, copies may also be sent to the customhouse broker and the consignee when either is not named as the importer of record. In any case, all persons who are issued a Notice of Sampling should also be sent the Release Notice.

To meet the various circumstances surrounding a release, the following variations of the Release Notice are currently used:

"STRAIGHT" RELEASE

This release form (or the computer generated notice from LISTS or OASIS) is issued whenever it appears, from sample examination or otherwise, that merchandise, for which a Notice of Sampling has been issued, is in compliance with the law.

Examples of LISTS or OASIS and Release Notices will be provided at a later date.

RELEASE WITHOUT EXAMINATION

Whenever a sample cannot be examined, for which a Notice of Sampling has been issued; a Release Notice form as identified in RPM page 344, "Straight Release" or the computer generated notice from LISTS or OASIS is issued amended as follows:

"RELEASED WITHOUT EXAMINATION MAY PROCEED WITHOUT FDA EXAMINATION ON THE RESPONSIBILITY OF THE IMPORTER"

This statement is typed in caps following the blocked information on the notice. An example of LISTS and OASIS or form will be provided at a later date.

RELEASE WITH COMMENT

Background

It had been the practice when an importation was encountered which did not fully comply with the requirements of the Act, but the violation was not a sufficient importance to warrant detention of the initial importation, to release the shipment with a "Release with Warning" that future similar violative importations might be denied entry. Although these "Releases with Warning" did not necessarily mean that the correction had to be made before the next importation, that frequently was the intent. The brevity of the warning often gave such notices an unintentional air of curtness.

Therefore, the "RELEASE WITH WARNING" and "RELEASE WITHOUT PREJUDICE" has been replaced with a "RELEASE WITH COMMENT" as a more flexible means of handling minor violations.

Approach

When an importation is encountered which does not fully comply with the requirements of the Acts which we enforce, but the violation(s) is (are) not sufficient to warrant detention on a first encountered basis, it may be "Released With Comment." The violation(s) must be minor, since a shipment with serious infraction(s) should be detained. For example, if an FPLA violation which is not considered subject to NLEA concerns is encountered in a product this shipment may be "Released With Comment. However, if the importer or country of origin has already received "notice" of our FPLA labeling requirements, the shipment may be detained.

A standard Release Notice is used with a notation "Release With Comment" prominently shown immediately following the blocked information on the notice. The comments may be placed directly on the Release Notice if sufficient space is available or, on an attached letter. If a letter is used, it should be stapled to the Release Notice and referred to in the body of the Form, i.e. "Release With Comment, See Attached Letter of (date)." An example of a "Release With Comment" is shown as Exhibit 9-1(examples LISTS or OASIS R/C notices will be provided at a later date.)

The violations on which the comments are based should be clearly covered by the Acts or regulations which we enforce. The comments should be stated in nonlegal language with reference to the specific sections of the Acts or regulations involved.

Generally, the Release With Comment should not be used if the problem is one commonly existing in domestic commerce and against which no FDA objection has been made. Center non-concurrence of detention recommendation that indicate non-agency support of similar domestic violation and past policy guidance with both domestic and imported products will serve as guide.

If the violation is clearly absent from similar domestic products, prompt correction should be requested by including the statement "Future shipments may be detained unless (nature of violation, i.e. misbranding) is corrected." By omitting this statement, the comments would serve as an information guide to provide a better understanding of the requirements of the law.

Before issuing a Release With Comment that includes a statement that future shipments may be detained we must be in a position to take action. However, other shipments that may be enroute at the time the comment issues or within a time frame established for correction to be completed be allowed to proceed if otherwise in compliance.

A statement on the Release Notice should be included directing the importer to advise the foreign manufacturer/shipper of our comments when applicable. A copy of this letter should be requested for the FDA file.

RELEASE AFTER DETENTION

Release after detention is issued in the following situations:

1. After the issuance of the Notice of Detention and Hearing (or computer generated notice from LISTS or OASIS) the importer of record or other designated agent may present testimony which shows that the merchandise is in compliance.

2. In response to the Notice of Detention and Hearing, the importer of record reconditions the merchandise to FDA's satisfaction pursuant to the terms of the Application for Authorization to Relabel or to Perform Other Action (Form FD-766), or else cause it to be brought outside the jurisdiction of the Act. The latter situation can occur, for example, when an importer diverts insect-adulterated, food-grade starch to industrial uses (paper manufacturing, etc.).

Under these situations, a Release Notice is issued with a notation "ORIGINALLY DETAINED AND NOW RELEASED" prominently shown following the blocked information or as appropriately set from the computer generated notice. If the merchandise has been reconditioned, the fact of this reconditioning should also be shown on the notice including the loss (if any) during reconditioning, reject material, the disposition of reject material, and amount of acceptable material. If supervisory charges are also involved, the notice should also bear the statement "Subject to bond liability for charges in connection with reconditioning."

EXHIBITS

9-1 Release with Comment

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SUBCHAPTER

AUTOMATIC DETENTION

PURPOSE

To provide uniform guidance regarding:

AUTHORITY AND BACKGROUND

Section 801(a) of the FD&C Act states, "If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions . . . or the facilities or controls used for the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f), or (2) such article is forbidden or restricted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation of Section 505, then such article shall be refused admission."

Congress authorized FDA to refuse admission of regulated articles based on information, other than the results of examination of samples, that causes an article to appear to violate the FD&C Act.

Information such as an article's violative history, among other things, may cause an article to appear adulterated, misbranded, or otherwise in violation of the FD&C Act, as described in Section 801(a).

Section 801 of the FD&C Act explicitly authorizes FDA to refuse admission of articles that appear to violate the Act.

That section also provides the importer with the right to "introduce testimony bearing on the admissibility of the articles." To carry out the provisions of Section 801(a), FDA detains an article that appears violative and provides notice to the importer of the nature of the violation and the right to present testimony regarding the admissibility of the article (21 CFR 1.94). Depending on the information submitted by the importer, the article may either be permitted or refused entry into the United States.

Automatic detention, first used by FDA in 1974, is appropriate when there exists a history of the importation of violative products, or products that may appear violative, or when other information indicates that future entries may appear violative. Automatic detention has the effect of reminding the importing community that FDA is a regulatory agency, not a quality control laboratory. Often, importers wait until the Agency has issued a Notice of Detention to determine whether the articles they are offering for import comply with the FD&C Act. Automatic detention properly places the responsibility for ensuring compliance with the law on the importer.

PROCEDURAL GUIDANCE

Any FDA unit may recommend automatic detention or removal from automatic detention when it believes that such action is warranted. Such recommendations should be in writing and submitted with supporting data and/or information to the office of Regional Operations (ORO), Division of Import operations and Policy (DIOP).

NOTE: Wherever feasible, recommendations should be submitted via electronic means in the appropriate format rather than via hard copy.

Supporting information should include an analytical package and documentation of center concurrence when no direct reference field authority exists.

Automatic detention may also be recommended on the basis of analyses performed by state or local agencies where FDA has determined that the sampling and testing conducted by such agencies is accurate, acceptable and representative of the product on which the recommendation is based.

Based upon local district history, District Directors have the discretion to consider placing future shipments coming through their ports from a particular packer, manufacturer or shipper, under detention where a recommendation for automatic detention has been made for DIOP concurrence, but has not yet been approved. Shipments of this nature do not require additional sampling.

RECOMMENDATIONS INVOLVING PESTICIDE RESIDUES

The Center for Food Safety and Applied Nutrition (CFSAN), Office of Field Programs (OFP), Division of Enforcement (DOE), Imports Branch (IB), will be responsible for review and concurrence of automatic detention recommendations involving pesticide residues for which no tolerance has been established. Copies of recommendations for automatic detentions involving this type of violation should be sent concurrently to OFP and DIOP.

Recommendations for automatic detention due to pesticide residues for which there is an established tolerance should be submitted directly to ORO/ (DIOP).

DIRECT REFERENCE AUTHORITY RECOMMENDATIONS

Certain recommendations for automatic detention are assumed to have CFSAN or CDRH concurrence. These detentions include recommendations involving ceramicware that appears to be contaminated lead or cadmium at levels above those stated in current Agency guidance (CPG 7117.06 - Section 545.400 and 7117.07 - Section 545.450); recommendations for automatic detention of ready to eat seafood and imported cheeses due to the presence of Listeria Monocytogenes; recommendations involving Salmonella in ready to eat seafood; recommendations for the automatic detention of surgeon's and patient examination gloves; and recommendations for the automatic detention of latex condoms. This list is not all inclusive.

RECOMMENDATIONS BASED ON EIR'S, OTHER GOVERNMENT

AGENCIES, MOU'S, ETC.

When inspections conducted by FDA, or by foreign or other government authorities under a Memorandum of Understanding (MOU) or other agreement, reveal conditions or practices warranting detention of either particular products or all products manufactured by a firm, or in a specific geographic area, the appropriate Center, upon recommendation from ORO's Division of Field Investigations (DFI), International and Technical Operations Branch (ITOB), and receipt of the Establishment Inspection Report (EIR) or other documentation, should submit a recommendation for automatic detention to DIOP. DIOP will review the recommendation to assure that all necessary supporting information is included prior to issuance of the guidance. When the responsible Center is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation, the Center will notify DIOP of its recommendation to remove the automatic detention action.

DIOP RESPONSIBILITIES

When a recommendation for automatic detention is received, DIOP will review the recommendation including supporting data/information and review national detention data (if necessary) to determine whether automatic detention is appropriate. (See RPM page 347 through page 349, setting forth guidance for determining whether automatic detention is appropriate).

Recommendations, formatted as Import Alerts or revised Import Alerts, will be offered for agency clearance by DIOP. (See RPM page 364, "Import Information Directives" for clearance procedures).

DIOP serves as the central repository for all automatic detention information and data. It is also responsible for reviewing automatic detention recommendations to ensure that they are timely, and that the Import Alerts are disseminated and revoked as appropriate.

AUTOMATIC DETENTION RECOMMENDATIONS

Automatic detention should be recommended whenever there is information that would cause future shipments of a product or products offered for entry to appear violative within the meaning of Section 801(a). The recommendation may be based on the violative history of a product, manufacturer, shipper, grower, importer, geographic area, or country. The recommendation may also be based on other information, such as information that food offered for entry was harvested from polluted waters, or information that a product was manufactured or held under insanitary conditions, or manufactured in non-compliance with Good Manufacturing Practice (GMPs), pursuant to Section 801(a) of the Act. An automatic detention may be recommended for an article with no prior history of detentions if the recommendation is adequately supported by information that indicates that future shipments may be violative.

RECOMMENDATIONS BASED ON ONE VIOLATIVE SAMPLE

Under this circumstance, FDA has evidence that at least one sample has been found violative and the violation represents a potentially significant health hazard. The sample collection and/or analysis may have been conducted by FDA or another reputable Federal, State, or local agency.

In the following instances, one violative sample, collected while a product is in import or domestic status, may support a recommendation for automatic detention of products from a specific manufacturer, shipper, grower, or from a specific growing area or country (if information is sufficient to establish an appearance that the violation extends to that area/country):

1. The product may have adverse health consequences. The appropriate Center, in most instances, would conclude that the problem would warrant a Class I or Class II recall.

2. The product (fresh, frozen, or processed) contains actionable levels of a pesticide residue, aflatoxin, or chemical contaminant.

3. The product is a violative low acid canned food, or acidified food. (i.e., failure to have a process on file for a specified product or no registration).

4. The product is violative in a way that is likely to continue due to the product's ingredients or formulation. For example, products which bear or contain undeclared significant ingredients (i.e., human allergen), unapproved colors, or violate their applicable standard of identity, or products that are unapproved new drugs, or unapproved new animal drugs, will continue to appear violative until the manufacturer of such products changes the label or formula for the products or obtains agency approval necessary for legal marketing.

5. The product is a post amendment device that is not subject to an approved 510(k) or premarket approval application. A copy of the recommendation should be sent for concurrence to the Center for Devices and Radiological Health (CDRH), Office of Compliance (HFZ-300).

6 . The product's labeling is violative and/or not in accordance with the Nutritional Labeling and Education Act (NLEA) and such violation is likely to continue until said labeling is corrected by the manufacturer. (See CFSAN Compliance Program for specific guidance)

Recommendations for automatic detention based on one violative sample should include documentation of Center concurrence, if such concurrence is required.

Center concurrence is not necessary when the action is covered by direct reference authority, as indicated by, among other things, a Compliance Policy Guide. Recommendations should also include a copy of the analytical package.

RECOMMENDATIONS BASED ON INFORMATION AND HISTORICAL DATA

When there is evidence that a product from a specific geographical area or country could pose a health hazard, the appropriate Center or district should recommend automatic detention. In such cases, where there is also information that the product is likely to continue to be violative, it may not be necessary to collect and analyze a physical sample.

Automatic detention may be recommended for products offered for import from a manufacturer, shipper, grower, geographical area, or country based on information showing a pattern of importation of articles that violate the FD&C Act. The information in the recommendation establishing a pattern of continuous violations of the FD&C Act should indicate that actions necessary to remove such violations have not been taken. In such cases, the guidance outlined immediately below would not necessarily apply. Center concurrence is, however, necessary in this situation.

RECOMMENDATION BASED ON MULTIPLE SAMPLES

Recommendations for automatic detention based on multiple samples showing violations of the Act should include documentation of Center concurrence with the recommended detentions, or copies of analytical packages if Center concurrence is not required, i.e., where direct reference authority is applicable. Recommendations for automatic detention may be submitted for:

1. Specific product(s) from an individual manufacturer or shipper for violations that do not pose a significant public health hazard, such as decomposition, filth, labeling, etc., when:

2. Specific product(s) from a country or a specific geographic area when:

3. Multiple products from a manufacturer or shipper when:

AUTOMATIC DETENTION OF IMPORTERS ENTRIES

Importers bear the primary responsibility for ensuring that products they import comply with all provisions of the FD&C Act. To carry out this responsibility, they may choose to inspect the foreign manufacturers or growers of products that they import, to enter into agreements with foreign exporters, to make arrangements to have products privately examined and analyzed prior to importation, and/or to take other steps to verify proper labeling and compliance of products with the FD&C Act before offering them for distribution into U.S. commerce.

If districts have documented an importer's practice of repeatedly offering violative articles for importation and attempting to recondition such shipments only after FDA detention, or of repeatedly attempting to export shipments or withdraw entries after receiving a notice of sampling or other indication of FDA interest (e.g., inquiries regarding product location), automatic detention should be recommended covering either specific commodities or all FDA regulated products offered for entry by that importer, as warranted.

Based on a review of district detention data, districts may recommend that an importer be placed on automatic detention when the importer exhibits a high percentage of violations of a single product, a group of products, or all products. All such recommendations, formatted as Import Alerts, should be submitted to ORO/DIOP for clearance. Each recommendation should include suggested charges; however, final charges to be used will be determined by the appropriate Center with input from the FDA Office of the General Counsel as needed.

RECOMMENDATIONS BASED ON ESTABLISHMENT INSPECTION

Establishment inspections of foreign manufacturers of FDA regulated products that reveal significant deviations from Good Manufacturing Practices, insanitary conditions, or other practices that result in the articles manufactured at such facilities appearing to be misbranded, adulterated, or otherwise in violation of the FD&C Act as described in Section 801(a) should result in the recommendation of automatic detention of the articles offered for import from such manufacturer. The appropriate Center(s) should review the recommendation and approve the scope of the action based upon review of the establishment inspection report or other evidence.

The automatic detention described above may identify one firm, multiple locations of a firm, or specific products from one or more firms as appropriate. The factors to be considered in the determination of whether to place a manufacturer's articles on automatic detention may differ from Center to Center and may be revised as Agency priorities and initiatives change. Recommendations following FDA inspections of foreign manufacturers will be made by ORO's Division of Field Investigations (DFI), International and Technical Operations Branch (ITOB), to the appropriate Center, with a copy to DIOP. The final automatic detention decision rests with the Center.

OTHER SITUATIONS

In cases other than those described above, a recommendation may be made for automatic detention if there is a reason to believe, and evidence to support, that future shipments of a product or class of products will appear violative within the scope of Section 801(a).

PARTY NOTIFICATION OF AUTOMATIC DETENTION

DECISION

The parties notified regarding the issuance of an automatic detention will vary depending on the nature and scope of the action. In most instances, a copy of the Import Alert will suffice for notification. The procedures for notification to the appropriate agency, foreign government, association and manufacturer/shipper and the agency units responsible for initiating the notification are as follows:

If notification of the specific foreign manufacturer or shipper is deemed impractical or impossible due to incomplete information, distance, communication difficulties, etc., notification should be sent to the importer, requesting transmittal of the notification to the foreign manufacturer and requesting a response to include what steps were taken to correct the conditions which brought about the automatic detention.

f. Industry associations as appropriate, (Centers).

REMOVAL FROM AUTOMATIC DETENTION

A product, firm, shipper, etc., is placed on automatic detention because information indicates that the product offered for entry appears to be either manufactured, processed or packed under insanitary conditions; forbidden or restricted for sale in the country in which it was produced or from which it was exported; adulterated, misbranded, or in violation of Section 505 (unapproved new drug); or appears violative as set forth in Section 536(a).

FDA decisions to remove a product, manufacturer, packer, shipper, grower, country, or importer from automatic detention should be based on evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved and the agency has confidence that future entries will be in compliance with the Act.

Shippers are placed on automatic detention when the identity of the manufacturer of the product that appears violative cannot be determined. Since there is no assurance that any subsequent shipments offered for entry are from the same manufacturer, the guidance set forth in RPM pages 351 - 352, below, will not provide the Agency with the information necessary to establish that the appearance of a violation has been removed. Therefore if after a six-month period a shipper on automatic detention has not offered for entry any shipment that is violative, AND can provide documentation to FDA indicating what steps the shipper has taken to ensure that he or she does not offer for entry articles that do not comply with the FD&C Act, such shippers may be removed from automatic detention. Shippers that are on automatic detention may offer evidence that products from specific manufacturers are not violative and should not be subject to the automatic detention using the guidance set forth in RPM pages 351 - 352. However, if the manufacturer of the violative product is subsequently identified, removal of such product from automatic detention should be based on specific information that overcomes the appearance of a violation and should be submitted by the manufacturer, not by the shipper.

If a product has been placed on automatic detention because it appears violative under Section 801(a)(1) or (2), analysis of samples from representative shipments will generally not be sufficient to overcome the appearance of the violation and warrant removal from automatic detention. An establishment inspection, or other appropriate action, may be required (i.e., documentation that a product is no longer forbidden or restricted for sale from the government of the country in which it was produced or from which it was exported).

For those products automatically detained because they appear to be violative under Section 801(a)(3), a minimum of five (5) consecutive non-violative commercial shipments should be entered before the agency may consider that the appearance of the violation has been overcome, and that it may be appropriate to remove the automatic detention.

NOTE: At least one of the five (5) non-violative entries should be audited by FDA to ensure the validity of the analysis.

However, depending on the nature of the apparent violation, a proper registration, scheduled process filing, 510(k) substantial equivalence order, Premarket Approval Application (PMA), NDA or NADA, or other documentation may be necessary before the appearance of a violation is overcome and the automatic detention is removed. If during the review to determine whether the appearance of a violation has been removed an apparently violative entry is offered, the review process for removal from automatic detention may be discontinued until information is submitted to show that the problem leading to the entry of the violative articles has been corrected. Under some circumstances, more than the minimum number of incompliance consecutive shipments may be necessary to establish that the violative practices or conditions have been fully resolved. For example, a shipper, grower, etc., who after being removed from automatic detention once again begins to ship the same type of violative products, may need to present more than five consecutive non-violative shipments to remove the appearance of a violation and to be considered for removal from automatic detention. When there is a continued history of entry of the same non-compliant product(s), documentation showing that the cause of the violation has been fully corrected may also be necessary.

DIOP shall consult with the appropriate district regarding a proposal to remove a firm or product from automatic detention. An important element of FDA's decision to remove a product, shipper, or importer from automatic detention is the extent to which the evidence shows that future shipments will be in compliance with the FD&C Act and implementing regulations. Splitting shipments into several entries or lines should not be considered as a means to increase the number of non-violative shipments. FDA needs to be confident that articles offered for importation are in compliance not just on one day, but over the course of a reasonable time period. Otherwise such articles will continue to APPEAR violative. If there is reason to conclude that two or more entries (or lines) represent a single related shipment or lot, these should be considered to be a single shipment.

Shipments should represent routine commercial entries, and should not be divided or staged, such that they are presented essentially for the purpose of removing a product, shipper, country, or importer from automatic detention. Shipments that consist of less than 10 to 15 cartons, which do not represent normal industry practice (e.g. high value food such as specialty cheese, etc.), may not be considered in the automatic detention removal process. FDA needs to be certain that adequate product is available for representative sampling and private laboratory analysis, as well as for possible audit sampling by FDA. (Refer to Laboratory Procedures Manual (LPM), Chapter 21 for guidance regarding private laboratories). The Division of Field Science (DFS) HFC-140 should be contacted regarding the acceptance/non-acceptance of laboratory data.

Shipments presented for consideration for removal from automatic detention should be in compliance with the FD&C Act or other statutes enforced by the Agency. Special situations may occur in which data presented may not conclusively demonstrate full compliance of the entry with the FD&C Act. In such situations, district staff may have additional information which, while allowing the shipment to be taken off of automatic detention, may still preclude the shipment's release.

REMOVAL OF PRODUCTS MANUFACTURERS/COUNTRIES EXCEPT FRESH PRODUCE

Recommendations for removal from automatic detention should be forwarded to DIOP for review when the district or other interested parties present documentation which establishes that the appearance of a violation has been removed. This documentation should include the examination records (analytical worksheets) from any private laboratory, foreign government, or from the FDA laboratory that analyzed the product, as well as documentation of the subsequent release of the shipments by FDA. In addition, other documentation may be necessary to verify that violative conditions no longer exist, e.g., product formulation information, information establishing label revisions, information showing a change in the use of food or other chemical additives, etc. The following guidelines should also be met:

NOTE:

For automatic detentions based on country or geographic problems with a product, shippers should not be removed from automatic detention. Shippers should ensure that the manufacturer of the articles they import is shown on entry documents so that FDA can determine whether the manufacturer has corrected the Problem(s) with the Products.

REMOVAL OF FRESH PRODUCE

Chemical Contamination:

Recommendations to remove fresh produce from automatic detention for chemical contamination may be made by the district upon consideration of all relevant information and criteria. DIOP should be notified of all such recommendations.

Pesticides:

Once an illegal pesticide residue has been found, past experience has shown that future shipments of the affected food may likely contain the illegal residue(s) throughout the growing and shipping season, or longer. A district, or other interested party, may recommend removal of a grower from automatic detention when the grower has entered a minimum of five (5) consecutive recent shipments without violation and when:

1. The grower demonstrates through adequate documentation that the residue problem no longer exists;

OR

2. The country /grower /importer demonstrates through adequate documentation that each lot of produce to be offered for entry originated in fields that were not treated with the pesticide in question;

OR

3. Information is obtained demonstrating that the produce originated in untreated fields, including documentation on the types of pesticides used in the surrounding fields, the dates and method of pesticide application, and the results of analyses from a representative sampling of the allegedly untreated field or lot (i.e., along borders and mid section) showing that the product from the implicated field is in compliance;

OR

4. Information is obtained on the steps that have been instituted to prevent the occurrence of illegal pesticide residues in future shipments.

Recommendations to remove a product or firm from automatic detention may be made at any time if supported by information that demonstrates that automatic detention is no longer warranted.

DIOP will monitor import alerts concerned with the automatic detention of fresh produce to assure that an assessment is made by the districts and/or headquarters as to whether to remove or continue the automatic detention of a product/grower after its anniversary date.

REMOVAL OF IMPORTERS

If an importer has been placed on automatic detention for the first time for a specific product, a recommendation for removal may be appropriate after the importer supplies acceptable documentation that the last five (5) shipments of that product from a specific manufacturer entered in full compliance with the FD&C Act.

If the importer has been placed on automatic detention for the first time for multiple products, a recommendation for removal may be appropriate after that importer supplies acceptable documentation that the twelve (12) most recent entries were in full compliance. The twelve (12) entries should represent the range of products covered by the automatic detention and normally entered by the importer.

If an importer is on automatic detention and it is not the first time, a recommendation for removal may be appropriate after that importer supplies acceptable documentation that the ten (10) most recent entries were in full compliance, in the case of a specific product, or the last twenty-four (241 entries, in the case of multiple Products.

In addition, a request from an importer that he or she be removed from automatic detention should include in sufficient detail, the steps that he or she has taken to prevent the entry of products that appear violative in the future.

REMOVAL BASED UPON AN ESTABLISHMENT INSPECTION

Firms or products placed on automatic detention based on a violative establishment inspection, or because the products appear to have been manufactured in violation of GMPs, may generally be removed from automatic detention following a reinspection which in some instances may be performed by a reliable entity other than which performed the initial violative inspection) that confirms that corrective actions have been instituted and after concurrence by the appropriate Center. In some instances, a firm may present information or documentation sufficient to demonstrate that appropriate corrections are in place to overcome the appearance of a violation and, with the appropriate Center concurrence, may be removed from automatic detention.

NOTIFICATION OF REMOVAL FROM AUTOMATIC DETENTION

The same FDA units responsible for the initial notification of the imposition of the automatic detention, per RPM page 350, "Party Notification..." should notify the same parties of the removal of such detention.