CHAPTER 7

RECALL PROCEDURES

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CONTENTS

Purpose..........................................................271
Policy...........................................................271
General Statement of Responsibilities............................273
Responsibilities and Procedures - ACRA...........................274
Responsibilities and Procedures - District Office................274
Responsibilities and Procedures - OE.............................279
Responsibilities and Procedures - MPQA...........................280
Responsibilities and Procedures - DFSR...........................280
Responsibilities and Procedures - DCP............................280
Responsibilities and Procedures - Centers........................280
Responsibilities and Procedures - Office of Health Affairs.......283
Responsibilities and Procedures - Office of Public Affairs.......283
Attachments .....................................................283
Exhibits.........................................................296

PURPOSE

The purpose of this chapter is to provide operational policy, definitions, responsibilities, and procedures for agency units in their review and audit of all recall actions. (See also Investigations Operations Manual, Chapter 8 - Recall Activities.)

All units are expected to follow the requirements of this chapter. Some deviation from the procedures may occur, however, in the initiation of device recalls ordered under section 518 of the Food, Drug, and Cosmetic Act, corrective action programs (recalls) involving radiation emitting medical devices and electronic products, infant formula recalls, human tissue recalls, or other situations as they arise.

Guidelines delineating the responsibilities of industry in conducting recalls are in the Code of Federal Regulations. (See 21 CFR, Part 7-Enforcement Policy, Subparts A & C.)

POLICY

GENERAL

Recalls are an appropriate alternative method for removing or correcting marketed consumer products, including their labeling and/or promotional literature, that violate the laws administered by the Food and Drug Administration (FDA). They are generally more efficient and afford equal and more timely consumer protection than formal administrative or civil actions, especially when the product has been widely distributed.

Recalls may be undertaken at any time on the initiative of manufacturers and distributors to carry out their responsibility to protect the public health and well-being, or in response to a formal request by FDA.

INFANT FORMULA

The Infant Formula Act of 1980 and its 1986 amendments mandate that an infant formula manufacturer must promptly notify the Secretary if the manufacturer has knowledge that reasonably supports the conclusion that an infant formula shipment:
1. may not provide the required nutrients; or
2. may be otherwise adulterated or misbranded.

Then, if the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately recall shipments. It is a "prohibited act" for a manufacturer of infant formula who engages in a recall to (a) fail to request that retailers post notice of recall for a length of time specified by the Secretary; and (b) fail to report to FDA every 14 days on the progress taken to implement the recall.

Guidelines delineating the responsibilities of industry in conducting mandatory infant formula recalls are in the Code of Federal Regulations (21 CFR, Part 107, Subpart E).

MANDATORY DEVICE RECALLS

In 1990, the Safe Medical Devices Act was enacted. One of the provisions is section 518(e), mandatory recall authority. Issuance of 518(e) orders has been delegated from the Secretary to the Center Directors and Deputy Directors and to the Directors and Deputy Directors of the Offices of Compliance in the Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Center for Devices and Radiological Health. If the Agency finds that there is a reasonable probability that a device intended for human use would cause serious adverse health consequences or death, FDA shall order the manufacturer, importer, distributor, retailer, or any appropriate person to immediately cease distribution of the device and to immediately notify health professionals and device user facilities of FDA's order, and to instruct such professionals and facilities to cease use of the device. After giving the party subject to the order an opportunity for an informal hearing, FDA shall either vacate the order or amend it to include a recall of the device.

MANDATORY RECALL OF HUMAN TISSUE INTENDED FOR TRANSPLANTATION

On December 14, 1993, FDA issued an interim rule establishing a requirement for certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of 'human immunodeficiency virus' (HIV), 'hepatitis B virus' (HBV), and 'hepatitis C virus' (HCV) through the transplantation of human tissues. The rule, which took effect immediately, applies to human tissues (such as bone, ligaments, tendons, cartilage, skin fascia, and corneas) intended for transplantation. This rule does not apply to vascularized organs (livers, hearts, and kidneys), bone marrow, semen, human milk, or any tissue currently regulated by FDA as a device or biologic (blood and blood products, heart valves, corneal lenticles, and dura mater).

FDA REQUESTED RECALL

A request by the FDA that a firm recall a product is ordinarily reserved for urgent situations, and is directed to the firm that has primary responsibility for the manufacture and/or marketing of the product. Such a request by FDA is the first action of choice when the responsible firm does not undertake a product recall on its own initiative. FDA requested recalls are most often classified as Class I.

All FDA requests for firms to recall must have the approval of the Associate Commissioner for Regulatory Affairs (ACRA), except in those limited circumstances when the authority is delegated to a center director. In the latter case, center directors are responsible for keeping the ACRA appropriately advised.

As a matter of general policy, before FDA formally requests recall action, the agency will have evidence capable of supporting legal action. It is recognized, however, that there may be exceptions when a real or potential danger to health is involved, or when other similar emergency circumstances exist. The successful completion of either a firm initiated or FDA requested recall does not preclude FDA from taking further regulatory action against a responsible firm, but such action will be a factor taken into consideration by the agency when reaching a final decision.

INTERSTATE MILK SHIPMENTS

The FDA will not ordinarily be involved in classification and auditing of Interstate Milk Shippers (IMS) product recalls where such actions have been, or are being, handled expeditiously and appropriately by the state(s). However, the FDA district office in which the recalling firm is located must be assured that all states involved in an IMS plant's recall are participating in ensuring removal of the product from commerce and that, when appropriate, states issue warning to protect the public health.

However, in the event that FDA determines that the states are unable to effect the recall actions necessary, the Agency will classify, publish, and audit the recall, including issuance of a public warning when indicated.

RECALL EFFECTIVENESS

It is FDA policy that after a firm decides to recall its products and so notifies the agency and recipients of the products, the recalling firm has the responsibility to determine whether the recall is progressing satisfactorily. Because effectiveness checks aid in verifying that all known, affected consignees have received notification about a recall and have taken appropriate action, it is the obligation of all recalling firms to conduct effectiveness checks as part of their recall strategy. Only in this way can the firm fulfill its responsibility to FDA and consumers.

The agency recognizes, however, that in some instances a recalling firm may not be able to check the effectiveness of its recall; for example, when a recall extends to the consumer-user level, or the confidential business records of a firm's customers are not accessible, or wholesalers, distributors, or retailers do not cooperate, or, because of the urgency of the situation, an all-out effort is required. In such cases, FDA will directly assist in this activity and, where necessary, seek assistance from cooperating State and local agencies.

Furthermore, the FDA recognizes that effectiveness checks also serve an audit function, and the agency reaffirms its policy of closely monitoring recalls and assessing the adequacy of a firm's recall efforts. Therefore, as part of its audit responsibilities, FDA will selectively conduct audit checks separately from the effectiveness checks of the recalling firm.

RECALL STRATEGY

Each circumstance necessitating a recall is unique and requires its own recall strategy. FDA will review and/or recommend the firm's recall strategy, and will develop a strategy for its own audit program based on the agency's hazard evaluation and other significant factors such as type or use of the product, distribution pattern, market availability, etc. The need for publicity, the depth of the recall, the level of effectiveness and audit checks, and other recall implementing factors will be a part of the recall strategy. The strategy is separate from, and not tied to, the class of recall selected.

PUBLICITY

FDA will include classified recalls in the agency's weekly Enforcement Report regardless of age or status. The recall status such as "completed" or "ongoing" will be published.

Additionally, notices or warnings may be issued to the general public and/or health professionals, trade associations, etc., for the purpose of alerting these populations to either serious health hazards or other situations deemed to be in the public interest. Publicity may be issued by either the recalling firm or FDA.

GENERAL STATEMENT OF RESPONSIBILITIES

The FDA will give recalls priority attention at all levels of the agency and will:

Assess the hazard presented by a product being recalled or considered for recall.

Formalize the recall action:

When the recall is FDA requested, by notifying the firm of FDA's determination of the need to immediately begin a recall. Such notification will specify the violation, the health hazard classification, the recommended recall strategy, and any other instructions appropriate to the conduct of the recall.

When the recall is FDA ordered, by issuing a written order to the firm to recall. This written order should state the violation and the section of the Act or CFR that gives FDA the authority to order the recall. It should clearly describe the product, lots, serial numbers, etc. to be recalled and provide a time frame for the firm's reply.

When the recall is firm initiated, by reviewing the information submitted by the recalling firm under 21 CFR 7.46(a) and/or 7.71 (d) and advising the firm of the assigned recall classification, recommending any appropriate changes in the firm's recall strategy, and advising the firm that its recall will be placed in the FDA Weekly Enforcement Report and, when appropriate, otherwise publicized.

When the recall is of a radiation emitting electronic product, by including in FDA's notification of a product defect or of noncompliance with standards, and the need for prompt response.

When product defects present hazards that require extensive design and/or test time to assure both the firm and FDA that a certain recall/corrective action program is appropriate, by requiring prompt preliminary communication to consumers/users to prevent unnecessary injury.

Audit the recall operation by developing and implementing a recall audit program which will include:

1. Monitoring the progress of the recall by reviewing periodic recall status reports received from the recalling firm and/or reviewing documentation of the recall operation and its effectiveness during visits to the firm.

2. Conducting audit checks in Class I and II recall situations to verify that consignees at the recall depth specified have received notification and have taken appropriate action.

Exceptions will be made only when circumstances indicate that such checks will be of no significant value in FDA's audit of the recall.

The FDA audit program for Class III recalls will not normally include audit checks. However, the responsible district and center office must consider the need for such checks in each recall situation.

Utilize the systems and relationships that the

(DMPQA) has established with the Department of Defense (DOD), Department of Veterans Affairs (DVA), General Services Administration (GSA), and Health Resource Services Administration (HRSA) whenever there is a need for information or cooperation which involves a serious recall situation of drugs or devices shipped to these agencies.

Determine when a recall should be terminated and, upon such determination, provide written notification of termination to the recalling firm.

Pursue regulatory action and/or other measures when a firm refuses to recall or sub-recall after being requested to do so by the FDA, where a firm fails to complete a recall in a timely fashion, or where the agency has reason to believe that a recall strategy is not effective.

RESPONSIBILITIES AND PROCEDURES - ASSOCIATE COMMISSIONER FOR REGULATORY AFFAIRS

Establishes agency general recall policy and procedures.

The ACRA has direct responsibility for approval of all FDA requested recalls and class I recalls. The ACRA may delegate designation of certain class I recalls to Center Directors.

RESPONSIBILITIES AND PROCEDURES - DISTRICT OFFICE (MONITORING DISTRICT)

RECALL ALERT

Within 24 hours of learning that a recall is being planned or is underway, notify the appropriate Center recall unit and OE (HFC-200), as described in Attachment A of this Chapter. Alerts are not required for recalls under section 518(e), blood product recalls for which CBER issued an "alert to possible recall", and corrective action program (CAP) recalls involving radiation emitting medical devices and electronic products. If the district learns of a completed recall, the recall alert can be combined with the recommendation. The format to be used is the same as for the recall recommendation, but flagged "Alert Recommendation for recall." The "District Aware Date" should be noted at the top of the document under the flag.

RECALL RECOMMENDATION (RR)

Within five working days after submitting the alert to an ongoing recall, prepare and submit a complete recall recommendation (RR) which includes the recalling firm's strategy, a historical assessment of the firm's ability to conduct an effective recall, and a recommended FDA audit program to the appropriate Center recall unit, with information copies to OE, the Associate Commissioner for Public Affairs (ACPA), Rockville (HFI-20), and the ACPA staff (Enforcement Report preparation), Washington (HFI-21). Recommendations for device recalls should also be sent to Office of Science and Technology (HFZ-100) and Office of Health and Industry Programs (HFZ-200). Up to 10 working days may be used to submit the Alert/RR when the district learns of a confirmed completed recall.

Note
- For veterinary drug products under recall, include information requested in the Recall Recommendation, Attachment B, item 4.
- Submit the 510(k) number for device recalls.
- When requested by OE or the Center, submit a Recall Recommendation for a product removal as a result of actual or alleged tampering with individual unit(s) where there is no evidence of manufacturer or distributor responsibility. The District's evaluation should state that the action is considered a market withdrawal.

For the product(s) involved, submit as soon as possible to the appropriate Center recall unit, legible copies of all labeling, FDA and/or state laboratory worksheets, and/or the firm's pertinent quality control/analytical records. If the district does not obtain a physical sample to demonstrate the defect and the potential hazard, other documentation of the need to recall, such as copies of FD 483's related to serious violations of GMP's, must be submitted. This material should closely follow the submission of the RR.

NOTE: The format and the information to be contained in the RR for (1) and (2), are described in Attachment B.

If there is insufficient information to submit a RR, the district recall coordinator will telephone the appropriate Center recall unit for advice on a course of action. In addition, the district recall coordinator will telephone OE to advise ORA.

If the recall has been completed by the firm at the time the district is obtaining recall recommendation information, the district should collect documentation that the recall has been completed and all product disposed of or corrected. The district should then combine the recommendation and termination.

Note: If the center recall unit or OE finds the information in the combined document lacking in any way, either may request that the district prepare a conventional termination with the additional information requested.

Note: The format and the information for the combined recommendation/termination is described in Attachment B-1.

RECALL STATUS FOR PRESS OFFICE

Upon receipt of the recall classification from the center, the district recall coordinator will promptly call or BANYAN the Press Relations Staff (HFI-21) and report the status of the recall as ongoing or completed. This information will be used in preparing the weekly Enforcement Report and responding to inquiries.

RECALL NOTIFICATION (RN)

Within two working days of receiving the recall number, strategies, and classification from the center, the district recall coordinator will:

1. Prepare a recall notification (RN) as described in Attachment C. The notification will be flagged Recall Notification (Class I, II, or III) (Firm Initiated), (FDA Requested) or (FDA Ordered) Recall."
2. Transmit the "Recall Notification" electronically to OE for placement into the FINOR (FDA Initial Notification of Recall) computer retrieval system.
3. Copies of any recall notification communiques (letters, response cards, mailgrams, etc.) prepared by the firm should be forwarded immediately to the Center recall unit. Transmit copies of all firm press releases to center recall unit, OE and ACPA, HFI-20 and HFI-21.

NOTIFICATION OF STATE OFFICIALS

District offices will furnish appropriate information to State and local officials as warranted in each situation and will arrange for any necessary assistance by state and local officials either in conducting or auditing the recall. See also RPM page 280, "Responsibilities/Federal State Relations."

FOREIGN, MILITARY, AND OTHER FEDERAL GOVERNMENT DISTRIBUTION

For Class I recalls, submit to OE a list of foreign, military, and other federal government consignees. Submit Canadian military, and other federal government consignees involved in Class II recalls. In addition, provide OE with Canadian consignees of Class III recalls. If Canadian distribution is refused, provide the name and phone number of responsible individual at the recalling firm so that it may be provided to Canadian officials.

ESTABLISHMENT INSPECTION

At the discretion of the monitoring district, an establishment inspection at the recalling firm should be conducted as outlined in IOM chapter 8 - Recall Activities. In many recall situations, the product's production location will be different from the location (usually headquarters or corporate offices) from which the recall is conducted. In these cases, it is the monitoring district's responsibility to contact the district where the violation occurred and request an in-depth inspection of the responsible establishment. The investigating district, in turn, should keep the monitoring district informed of the inspectional progress and findings and should specifically give attention to the following:

1. Obtaining the firm's proposed recall strategy as set forth in 21 CFR, Subpart C, Section 7.46(a), (1) through (9), if not previously submitted by the recalling firm.
2. Determining the need for an official sample, either physical or documentary. The decision to collect an official sample is a district management prerogative unless required by specific headquarters' initiated assignments, or the occasional direct request from the center recall staff or OE.
3. Collecting copies of all labeling associated with the product.
4. Obtaining complete distribution of all shipments of the suspect lot(s), including complete names and addresses of all foreign consignees.
5. Obtaining, if available, copies of all of the firm's quality control/analytical data which support the firm's decision to recall, including the methodology used by the firm to obtain such data.
6. For medical device recalls, obtaining marketing status of the device being recalled, that is, 510(k) or PMA number(s), or preamendment device with proof of status.

Prior to initiating an establishment inspection, district personnel should contact the following center and/or ORO units as appropriate to determine if complaints have been received of identical or similar situations: (1) Epidemiological Investigations Branch (HFC-161) regarding the possibility of injury/illness complaints; (2) CDRH's Division of Postmarket Evaluation (HFZ-520) regarding complaints in the Device Surveillance Network; (3) CDER's Product Surveillance Branch (HFD-333) regarding complaints reported in the Drug Product Defect Reporting system. Center offices managing other reporting systems may be contacted where applicable to a particular problem.

If the monitoring district office encounters unreasonable delays by the recalling firm, an administrative or legal action should be recommended to the appropriate center. The Center recall unit and OE should be kept informed of such recommendations.

If FDA becomes aware of a previously unknown "Completed" recall, appropriate documentation should be obtained by the district to classify and closeout the recall at the same time. See also RPM page 276, "Firm Initiated Recalls".

ASSISTANCE TO RECALLING FIRM

FDA-Requested Recalls

1. When the district receives a copy of the communique sent to the responsible firm by either the Associate Commissioner for Regulatory Affairs or a Center director requesting a recall, district personnel should verify the firm's receipt of the communique and make arrangements to visit/inspect the firm as soon as possible. Coordination with the center recall unit, Office of Criminal Investigations, or other offices may be necessary in special situation
.

NOTE: FDA requested recalls for radiation emitting electronic products may not always follow this procedure. Special instructions are in Attachment F.

2. The monitoring district office will offer guidance to the recalling firm and will assist the firm in arranging the text of recall communications to consignees so that the product will be promptly removed or corrected. If the depth of the recall is to the retail, hospital, physician or consumer level, the direct accounts should be instructed by the recalling firm to contact any sub-accounts which may have received the product.
3. The recall envelope, letter, mailgram, telegram, or other type of message should be flagged "URGENT DRUG (or FOOD, BIOLOGIC, DEVICE, etc.) RECALL (or CORRECTION)." Letters should be sent first class and, where appropriate, by certified mail. The notification should be brief and to the point. It should clearly identify the product, potency, dosage, type, model and/or lot number(s), contain a concise statement of the reason for the recall, known or potential hazard, and instructions for consignees to follow in handling the recall.
The possible necessity for bilingual or multilingual notifications should be explored with the firm's marketing offices.
4. The instructions should request direct accounts who are involved in further distribution of the recalled product to promptly initiate sub-recall efforts in a similar manner as indicated above. The written communique to sub-accounts should be in addition to any other means of notification, such as monthly sales bulletins, detailmen routine visits, or recorded phone messages on order taking equipment which, although certainly an aid in a sub-recall effort, are not considered adequate in and of themselves.
5. Letters to direct accounts and sub-accounts should include a postage-paid, self addressed post card, envelope, or other arrangement to enable the consignee to report the amount of the product available and the disposition being made. If none of the product is on hand, the consignee should be directed to submit a negative report. Prompt return of the card or other report should be stressed. (See Exhibits 7-1, 7-2, and 7-3 for model letters, envelopes, and cards.)

FDA Ordered Recalls

FDA ordered recalls often have timeframes and procedures specified in the CFR. The district should familiarize themselves with these before proceeding with assistance to the firm. The center compliance branch normally takes the lead in negotiations with firms on FDA ordered recalls. The district should plan its strategy with direction from the center.

Firm Initiated Recalls

During the initial investigation of a firm initiated recall, sections in RPM page 276, "FDA Requested Recalls (2-5)" above should be used.

Usually, during this initial contact, the center has not provided an evaluation of the hazard or a recall classification. In the absence of such center evaluation, the district office should not urge the firm to extend or reduce its recall efforts but rather determine the firm's recall strategy. The district will report the firm's recall strategy and provide an assessment of the strategy and firm's ability to meet that commitment in the RR. A copy of the firm's recall communication should be submitted to the Center recall unit. Copies of firm's recall communications for potential class I recalls should also be forwarded to OE.

NOTE: In all discussions of violative or potentially violative products with the responsible firm, it is necessary to exercise discretion and diplomacy to avoid any misunderstanding that FDA is formally requesting recall action. FDA requested recalls may be authorized only by the ACRA or by delegation of authority such as Drug Efficacy Study Implementation (DESI) recall requests.

The investigator should verbally apprise management that, when there is product to be returned for reconditioning or destruction, the district office should be consulted prior to the initiation of such action. Management should also be advised that FDA must witness or otherwise verify product disposition.

If the recall has been completed before FDA's knowledge of it, district personnel should obtain documentation of actions taken to dispose of or recondition the recalled products. This documentation may include processing records or laboratory analysis, signed destruction receipts, salesmen's written receipts, corporate official's signed statement on firm's stationery, etc.

FDA Conducted Recall

If the responsible firm is out of business or is unable to conduct an effective recall for any reason, the Center recall unit and OE should be notified. The monitoring district and the Center recall unit should develop an appropriate course of action to recommend to ACRA.

FDA/FIRM CLASSIFICATION/STRATEGY LETTER

The monitoring district, upon receiving the recall number, classification, and recall strategies from the center, may notify the recalling firm by telephone of the recall classification and upcoming Enforcement Report publication prior to issuance of the recall notification letter from the district director. The district will then promptly prepare and send a notification letter to the firm restating the agency's position with respect to the recall.

This letter will provide the recall number(s), the classification of the recall, an agency assessment of the firm's recall strategy, i.e., type of notification, depth of recall, and level of effectiveness checks, as well as any suggested strategy revisions. It will indicate FDA's determination to verify returned product disposition by stating that the district office should be notified prior to the initiation of reconditioning or destruction of recalled products and that such action should be witnessed by an FDA investigator. (An alternative means, such as verification by appropriate state or local officials, may be used.)

The notification letter should be prepared for the signature of the district director or his delegate. It should also include the name and telephone number of the district's recall coordinator to assist the firm in answering any questions related to the recall classification.

The letter should also inform the firm that the recall will be published in the FDA Enforcement Report. The letter should encourage proper corrective action, and request periodic status reports from the recalling firm as described in 21 CFR 7.53(b).

A statement will be included that failure to conduct an effective recall could result in either seizure of the violative product or other legal sanctions under the FD&C Act or related statutes.

A sample Notification Letter is attached as Exhibit 7-4. This exhibit serves only as a model. These letters should be written on a case-by-case basis and tailored to each unique recall situation.

In situations where there is an urgent need for a more prompt notice, i.e., FDA requested recalls, Class I recall, or pending FDA press release, the district office will visit or telephone the firm, and follow-up with a confirmatory letter as appropriate.

In instances where the recall is terminated at the same time it is classified, the district should prepare a combination notification/termination letter to the firm. This letter will provide the recall number(s) the classification of the recall, and indicate that FDA considers the recall terminated. A sample Notification/Termination letter is attached as Exhibit 7-6A.

MANAGING FDA'S AUDIT PROGRAM

The district director has the overall responsibility for

assuring that the FDA audit program is implemented. The recall coordinator and appropriate supervisory personnel are responsible for the day-to-day management of a recall. They will assure that the firm's status reports are received and reviewed in a timely manner, and that the disposition of recalled products is monitored or verified. Contacts with the recalling firm will be initiated either by telephone or establishment visit, as appropriate, to assure adequate progress and timely completion of the recall.

Normally within 10 days of issuance of the firm's recall communication, the monitoring district will issue audit check assignments at the level in the FDA audit program. Exceptions to the 10 day time frame are to be expected in certain radiation emitting devices and electronic product recalls. In these cases, follow CDRH recommended strategy. If the 10 day requirement is considered inappropriate by the district, a recommendation for a new date for issuance of audit checks should be made to the recall unit.

Audit check assignments are to be considered as high priority by receiving districts. They are to be accomplished as soon as possible and hard copy audit check reports immediately submitted to the monitoring district. Normally, 10 working days from receipt of the assignment should be adequate for their completion. The monitoring district must provide specific instructions as appropriate when issuing an assignment to another district office. For Class I recalls, audit check reports are to be provided to the monitoring district at least once a week and more often if so directed. The assignment should be flagged "Request for Audit Check--Class I or II, Audit Check--Level A, B, C, or D". (See Exhibit 7-7 for format).

A copy of Class I audit check assignments should be provided to the Center recall unit and to OE. The "audit check reports" should be maintained by the issuing district and evaluated upon receipt to determine their adequacy. If it becomes apparent that insufficient information is being collected, the issuing district recall coordinator will advise the endorsing supervisory investigator.

It is the responsibility of the receiving district to notify the issuing district of circumstances which will adversely delay the completion of the assignment. Copies of any such communication should automatically be forwarded to the Center recall unit and to OE (HFC-200).

Conducting Audit Checks - Direct and Sub-Accounts

The data to be obtained and the extent of follow up at consignees of recalled products is dependent upon several factors, including the depth of the recall and the type of recall action requested, e.g., return, field correction, or destruction.

Prior to the conduct of audit checks for complicated or significant recalls, the district may either prepare information handout sheets or make copies of the recalling firm's recall communication so that copies may be left with consignees.

1. No Sub-Recall Indicated

When sub-recall is not indicated by the consignee at which the audit check is to be conducted, determine if, how, and when the consignee was notified of the recall; determine whether recall instructions were followed. If the recalled product is being held for sale or use without notification instructions being followed, the investigator or inspector making the audit check should request immediate compliance with the instructions. If the consignee has not received the recall notification, provide necessary information for the consignee to perform the requested recall action.

2. Sub-Recall Indicated

Where sub-recall is indicated by the consignee at which the audit check is being conducted, determine if, how, and when the notification was received. If sub-recall has been or is being conducted, determine and report in detail how the sub-recall is being carried out. This report is to include the quantity of product involved, the timeliness of the action, and other data pertinent to the sub-recall.

If the consignee has not received notification of the recall, or has elected not to conduct requested action, provide the consignee with all pertinent recall data and/or request that recall instructions immediately be followed, including sub-recall. Provide any assistance or guidance needed to get a sub-recall underway.

3. Sub-Recall Refusals

If the direct or sub-account refuses to initiate recall promptly, the district in which the account is located will advise the monitoring district, OE, and appropriate Center recall unit of the situation, and indicate what additional steps they are taking to achieve a satisfactory sub-recall.

These steps should include such things as meetings between district management and top management of firms, notification of consignees directly, reporting to State and local officials, recommendation for FDA requested recall, initiation of administrative proceedings or enforcement actions, etc.

4. Responsibility

The district in which the direct or sub-account is located is responsible for recommending administrative or legal action, if indicated, to achieve compliance. The monitoring district, the Center recall unit, and OE should be kept advised of such recommendation.

5. Injury/Illness/Data

Injury/illness reports or other product related complaints should be reported promptly (separately from the audit check report) to the monitoring district and OE.

6. Audit Check Reporting

All reporting for recall audit checks should be accomplished on form FDA 3177, Recall Audit Check Report (Exhibit 7-8 and 7-8A).

Ineffective Recall

If at any time during FDA audit of the recall it is apparent that the firm's recall effort is ineffective, the monitoring district should discuss the situation with the recalling firm and determine what action the firm intends to take to improve its recall efforts such as issuance of additional recall communications, etc. Such contact can be made by visit, telephone, letter, telegram, etc., depending upon the circumstance. A model letter regarding ineffective recalls is attached as Exhibit 7-5. This type of letter should be developed by the district on a case-by-case basis working closely with the Center recall unit.

If, after this notification, the firm is unwilling to extend or modify its recall, the monitoring district will notify Center recall unit and OE of the situation and recommend appropriate action. Actions to be considered include: FDA-requested recall; initial or further public warnings; multiple seizures; injunction; etc.

TERMINATION OF RECALLS

For Class I recalls, upon a conclusion by the monitoring district that the recall was effective and that the proper disposition has been completed, a Recall Termination Recommendation will be prepared for submission to the appropriate Center recall unit for review and approval. This recommendation will be in the form of a factual summary of the entire recall effort. It will include the firm's and FDA's findings from monitoring and auditing the recall, especially the data on effectiveness/audit checks and/or other verification of recall effectiveness, and information on the disposition of the product.

Prior Center approval is not required for Class II or III recall terminations.

As a rule, the time from which the firm considers the recall completed to FDA recall termination should not exceed three months. Recalling firms should be advised that FDA will not terminate a recall until the recalled material is either brought into compliance or disposed of in an acceptable manner. If the district feels that the recalling firm is unable to ensure that violative goods will not reenter channels of distribution, the Center Recall Unit and OE should be consulted as to the best course of action.

NOTE: Before any FDA approval or concurrence is provided to plans for the disposition of recalled products, the district must follow established procedures governing the coordination of toxic wastes/product disposal programs with other federal or state agencies.

When the monitoring district has received center concurrence in its termination recommendation (Class I recalls) or has made its own determination regarding recall termination (Class II and III recalls), the district will notify the recalling firm in writing that the recall is terminated. A model termination letter is attached as Exhibit 7-6.

REPORTS AND REPORTING PROCEDURES

Identification of Recall Documents

Field installations should identify all associated communications and documents by recall number.

Audit Check Reports

See Exhibit 7-8 and guidance provided under RPM page 277 "Managing FDA's Audit Program".

Status Reports
1. Weekly
For each Class I recall (and certain Class II recalls as required by the audit program), the district office will send a weekly status report by word processor to Center recall unit and OE indicating progress of the recall, until the recall is completed or until advised otherwise by OE. (Exhibit 7-9A)
2. Bi-Monthly
For all recalls, the district office will send a bi-monthly status report (Exhibit 7-9B or word processor format) to OE and appropriate Center recall units indicating progress of the recall until the recall is terminated.

Recall Termination Recommendation/Summary of Recall

This dual purpose document, Recall Termination Recommendation/Summary of Recall, is to be prepared by the monitoring district upon determination that the recall was effective and proper disposition has been completed. See RPM page 278, "Termination of Recalls". This document will serve as the final summarization of recall activity and is to be distributed as indicated on Attachment D.

This summary is used at headquarters to determine trends and to evaluate new problem areas in manufacturing, processing, etc. State clearly in Section 3 of the report the specific problem causing the recall and provide a narrative discussion of all topics indicated. The discussion under item #18 of legal actions taken or contemplated must indicate concurrence by the chief of compliance branch.

RESPONSIBILITIES AND PROCEDURES - OFFICE OF ENFORCEMENT (HFC-200)

Serves as the agency focal point for information, advice, and direction regarding the field operations aspects of all recalls and the ORA contact with the district offices regarding all recall matters.

1. Together with the district office and the center recall unit, evaluates the adequacy of a firm's performance in implementing their recall strategy and encourages timely follow-up by districts on all recalls.

2. Receives and reviews a copy of all pertinent recall documents. If required, directs appropriate follow-up action. Promptly notifies ACRA of significant recall actions and provides copies of recall documents where appropriate.

3. Maintains liaison during each significant recall situation with the appropriate Center recall unit. Notifies the Center recall unit of all significant recall related injury or illness complaints. In appropriate situations, discusses Recall Action Memoranda with Center recall unit personnel prior to its submission to ACRA.

4. Routinely reviews and recommends to the ACRA approval/disapproval of FDA-requested recalls and Class I recalls for which authorities have not been delegated to Center Directors. OE review will be accomplished within one working day unless additional/supplemental review of a health hazard evaluation or recall classification/status is required.

5. Provides ORA concurrence regarding utilization of manpower resources for audit checks.

6. Contacts Office of Enforcement/Division of Compliance Policy when necessary for review of compliance policy issues.

7 Upon ACRA approval of Recall Action Memorandum, OE immediately notifies the appropriate center to issue the classification document to the field and the press office.

8. Requests the Associate Commissioner for Health Affairs (ACHA) to review and provide recommendations on health hazard evaluations or recall classifications where there are center/ORO disputes or where, in the view of the ACRA, the health hazard evaluation or recall classification warrants additional medical review.

9. Notifies the Division of Medical Products Quality Assurance (DMPQA, HFC-240) when medical products under recall (class I and class II) are found to have been distributed to any Federal agency; advises DMPQA about impending Class I and other serious recall situations of drugs and devices shipped to DOD, DVA, GSA, or HRSA facilities.

10. Notifies the Division of Federal-State Relations of Class I recalls for which publicity is anticipated, and the depth of the recall is to extend to the retail or consumer level.

11. When requested, assists the Press Relations staff in the preparation of publicity.

12. Notifies the International Affairs Staff (IAS) of all Class I recalls involving distribution to foreign countries other than Canada. When specific foreign consignees are identified, forwards appropriate information to IAS. Responds through IAS to all recall related requests received by the agency from American embassies.

13. When indicated, advises IAS of recall of imported products so that efforts may be made to locate all importers of the violative product.

14. Through an established communications agreement between the FDA and Health Protection Branch, notifies Canada of each recall (class I, II, and III) involving U.S. products shipped to Canada or of Canadian products recalled in the United States.

15. Notifies certain federal agencies and national trade associations that have mutual or complimentary responsibilities for recalls.

16. Periodically reviews all agency recall activities to assure that current policy and procedures are applied, and recommends changes as appropriate.

17. Evaluates on continuing basis the overall effectiveness of recall activities. Transmits pertinent information concerning trends, common causes necessitating recalls, control weakness, etc., to units having the need for this information.

RESPONSIBILITIES AND PROCEDURES DIVISION OF MEDICAL PRODUCTS QUALITY ASSURANCE (HFC-240)

Notifies appropriate federal purchasing agencies (DVA, HSA, DOD, and GSA) of all Class I recalls; and of those Class II recalls of medical products which have been distributed to federal agencies.

Receives and coordinates Class I recall audit check data from other government agencies. Forwards the data to OE.

RESPONSIBILITIES AND PROCEDURES - DIVISION OF ) FEDERAL-STATE RELATIONS(HFC-150

Informs State and local officials by electronic mail system of selected recalls due to serious health hazard; where intense publicity is anticipated, and/or where their assistance is requested. Distributes to these officials the weekly FDA Enforcement Report prepared by the Press Relations Staff/ACPA.

RESPONSIBILITIES AND PROCEDURES - OFFICE OF ENFORCEMENT/DIVISION OF COMPLIANCE POLICY (HFC-230)

Reviews/resolves compliance policy issues related to recalls. Reviews recall action memorandums when requested by OE or when a policy issue is otherwise identified.

RESPONSIBILITIES AND PROCEDURES - CENTERS

CENTER DIRECTOR

Establishes and oversees the center recall activities including the Health Hazard Evaluation Committee system.

Approves all recall Action Memoranda. Approves recalls ordered under section 518 of the FD & C Act and under the Public Health Service Act.

CENTER RECALL UNIT

General Responsibilities

The focal point within the center for the receipt, development, coordination, and dissemination of oecall information. Focal point within the center for technical and scientific aspects of recalls.

Initiating Health Hazard Evaluation and Reevaluation

Upon receipt of each recall recommendation or other information from any source which indicates a recall may be necessary, this unit determines whether an up-to-date health hazard review exists covering the situation. If not, forwards the appropriate information to the center Health Hazard Evaluation Committee for review. Also, forwards additional information received during the progress of a recall to the committee for timely health hazard reevaluation.

The Center recall unit should determine whether coordination with other centers is necessary and assure that such coordination takes place. Any questions about lead center responsibility or jurisdiction should be promptly referred to ORA/OE.

Recall Strategy Review or Development

Based upon the health hazard evaluation and any other pertinent data available, reviews and comments on both the recall strategy planned or underway by the recalling firm, and the FDA audit program recommended by the district office in the RR. For firm initiated recalls, Center coordinators should obtain current assessment of recall effectiveness from the field. Specifically: Center recommended changes in either the firm's strategy for recall and effectiveness check actions, and/or the FDA audit program will be communicated to the district recall coordinator immediately by telephone with further confirmation contained in the classification document. OE should also be immediately advised of the change.

1. FDA Requested Recall Strategy Development The Center recall unit will include as part of the Action Memorandum the recommended strategy for the responsible firm that FDA considers necessary for the prompt and effective conduct of the proposed recall. The strategy statement will also include the proposed strategy for FDA's audit program.
2. Firm Initiated Recall - Strategy Review
The Center recall unit will review, change as indicated, and/or concur in the firm's recall strategy and the district's recommendations for the FDA audit program.
3. FDA Conducted Recall

When a responsible firm is out of business or is unable to conduct a recall for any reason, the Center working with the involved district should recommend an appropriate strategy to ORA/OE.

Factors in Strategy Development

Take into account the health hazard evaluation, the ease in identifying the product, the degree to which the product's deficiency is obvious to the consumer or user, the amount of product remaining unused in the marketplace, and the continued availability of essential products.

Include a statement on, and the reasons for, recommending the desired option under each of the following elements:

1. Depth of Recall
2. Effectiveness Check Level
Comment upon the adequacy of the firm's proposed effectiveness check strategy.
3. Publicity

Actions classified by FDA as recalls will appear in the FDA's Enforcement Report.

Consideration should be given to the need for a Press Release which could be nationwide or to affected geographical areas only. In some cases, specialized communication with specific segments of the population (e.g., physicians, pharmacists, veterinarians, and hospitals) may be possible.

When information is to be issued in a press release or talk paper, in addition to the FDA Enforcement Report, it must be coordinated with HFI-20.

Reflect consideration of the disposition of recalled products (e.g., carcinogenic products) when normal disposition means, landfill, crushing, denaturing, etc., are inadequate.

Interim Recall Strategy

When necessary, an interim strategy should be developed by the center to cover the time between notification of a known or potential health hazard and completion of a final formal strategy. Interim strategies are frequently part of recalls conducted for radiation emitting devices and electronic products.

The interim strategy will indicate the immediate actions to be taken on the part of the responsible firm to assure prompt warning to the appropriate depth of distribution. Such warning must identify the hazards involved and the steps to be taken to minimize exposure to the product hazard pending completion and implementation of the recall strategy.

FDA Recall Audit Program Development

The Center recall unit has the responsibility for finalizing the FDA audit program. In carrying out this function, the district recommendations for the program will be reviewed and approved or revised as necessary.

In class I or other significant recall situations, the audit program must be regularly reviewed and updated by the Center recall unit to assure its adequacy and to reflect changes in the health hazard evaluation, classification, effectiveness of firm's recall, etc.

Factors in Audit Program Development include:

1. Special procedures for monitoring the recall at the firm.
2. Level and type of audit checks to be conducted.
3. Special reporting requirements.

Recall Classification

Class I recall designations for which authority has been delegated by the ACRA to the centers must have Center Director concurrence. All other classifications must have the concurrence of the Center Compliance Director or his/her designee.

Recall classification Action Memoranda for the ACRA approval must have the concurrence of the Center Director or his/her designee.

The Center recall unit will normally prepare a "classification notification" and transmit it by electronic mail or alternate means, to the monitoring district within two days of receiving the health hazard evaluation of an ongoing recall.

The Center recall unit will normally prepare a "classification notification" and transmit it by electronic mail, or alternate means, to the monitoring district within one week of receiving the health hazard evaluation of a completed recall.

Recall Action Memorandum Development

The Center recall unit will prepare the recall Action Memoranda in all situations requiring ACRA or Center Director approval. Copy of the following documents will routinely be attached: health hazard evaluation; the firm's or FDA's recommended recall strategy; FDA audit program; and the initial recall recommendation. As appropriate, product analytical results, medical records, evaluations, etc., which are pertinent to the hazard evaluation and subsequent recall classification, will also be attached. In the case of FDA requested or ordered recalls, the memorandum will also set forth the proposed course of action to be taken in the event that the firm elects not to recall.

NOTE: FDA will normally evaluate, prepare, and approve necessary action memorandum on infant formula manufacturers' notifications submitted in compliance with section 412 of the Act - Requirements for Infant Formulas - within five calendar days.

The Center and the field will be informed by ORA/OE (via phone) of the ACRA's decision. Copies of the final "approved" document will be distributed by the center as soon as they are available. The original action memorandum with appropriate signatures and comments will become a permanent part of the Center's recall file.

Classification Notification and Routing

Upon final approval of recall classifications, the Center recall unit will immediately notify the ACPA, Enforcement Report Staff (HFI-21) with the product, recall number, reason for recall, and classification for publication in the FDA Enforcement Report. This notification will also be sent to the monitoring district with information copies to OE and to the Press Relations Staff (HFI-20).

Publicity

Assist the Press Relations Staff (ACPA), along with OE and the monitoring district, in the preparation of FDA publicity.

HEALTH HAZARD EVALUATION COMMITTEE

Initial Determination

The committee will conduct a health hazard evaluation of products either under recall or being considered for recall. This evaluation will take into account the factors listed in 21 CFR 7.41(a)(1)-(6) and section 5-00-20(H) of this part. The health hazard evaluation report must be prepared by knowledgeable center personnel and should reflect their written concurrence. Attachment E provides additional guidance to be used in preparing Health Hazard evaluations. It is the responsibility of the Health Hazard Evaluation Committee to assure themselves that all reviewers are familiar with the intent of the evaluation.

The health hazard evaluation report will be completed, endorsed, and provided to the Center recall unit within two (2) working days after receipt of a recall recommendation for a potential or ongoing recall unless additional information is required. It is the responsibility of the committee to notify the Center recall unit of any informational deficiencies.

The health hazard evaluation report will be completed, endorsed, and provided to the Center recall unit within (5) working days of receipt of a recall recommendation if the recall recommendation indicates that the product is no longer in distribution channels.

Health Hazard Reevaluation

In all situations where additional data regarding injury, illness, medical, or scientific findings is received by the Center following the initial health hazard evaluation, a prompt reevaluation must be carried out. Where additional data are being received on a continuing basis, the committee is to routinely meet and reevaluate the health hazard at least biweekly.

COMPLIANCE DIVISION DIRECTOR (OR EQUIVALENT)

Is responsible for the day-to-day functions, operations, and decisions of the Center recall unit.

Assures that the regulatory strategy cited in the recall recommendation and the action memorandum is supportable in the event the firm elects not to conduct a voluntary recall or fails to terminate a recall in a timely fashion.

Reviews and concurs with all recall classification communications.

Concurs in all Action Memoranda.

RESPONSIBILITIES AND PROCEDURES - ASSOCIATE COMMISSIONER FOR HEALTH AFFAIRS

IMMEDIATE OFFICE OF THE ASSOCIATE COMMISSIONER

At the request of the ACRA, reviews and makes recommendations on health hazard evaluations or recall classifications when in the view of ACRA there are ORO/center disagreements or where the health hazard evaluation or recall classification is questionable.

INTERNATIONAL AFFAIRS STAFF

For all Class I recalls involving foreign consignees other than Canadian, summarizes and transmits essential information to the appropriate American Embassies through the Department of State. Provides copies of this information to the Center recall unit and OE.

Upon OE advisement of need to do so, requests appropriate American Embassies, through the Department of State, to contact foreign manufacturers or distributors in order to determine name(s) and location(s) of United States importers of the firm's product(s) found to be violative and under recall in the United States. Provides embassy responses to OE.

Coordinates the development of responses to embassy inquiries with the centers and OE.

Provides embassy responses regarding the effectiveness of recall actions to Center recall unit and OE so that the effectiveness of the recall notification to foreign consignees may be properly evaluated.

RESPONSIBILITIES AND PROCEDURES - ASSOCIATE COMMISSIONER FOR PUBLIC AFFAIRS

Advises the ACRA on the appropriateness of publicity for all recall actions.

When strategy includes publicity, prepares and issues publicity with the assistance of the appropriate center, district, and OE. Obtains ACRA approval on all recall publicity.

Alerts the appropriate home district of the expected release of publicity.

Through the Press Relations Staff (HFI-21), assures that recall actions are included in the FDA Enforcement Report. Specifically, the staff will:

1. Upon receipt of the Recall Recommendation from the district, extract the preliminary data needed for the FDA Enforcement Report.

2. Complete the recall entry for the FDA Enforcement Report upon receipt of the recall classification and number from the Center Recall Unit, and the immediate recall status report from the monitoring district office. Coordinates the development of the draft and final report with the Center recall units and OE.

3. Distributes the report to ORA headquarters and field offices, the press, other federal government agencies, consumers, and the Center recall units.

In cooperation with the Center recall unit and OE, prepares "Talk Papers" on high interest recalls which do not warrant a press release.

Evaluates the effectiveness of the publicity and, if determined to be inadequate, initiates action to assure effective notice.