Inspections, Compliance, Enforcement, and Criminal Investigations
7-5 - INITIATION OF A RECALL
A manufacturer or distributor may voluntarily initiate a recall at any time. FDA may conduct informal discussions with a manufacturer or distributor that include voluntary recall as an option. FDA may also request a recall, as provided for under 21 CFR 7.45. Under certain authorities, FDA may mandate a recall.
In summary, if a recall is firm-initiated under 21 CFR 7.46, the agency will obtain and review the information provided by the recalling firm under 21 CFR 7.46(a). This includes reviewing and suggesting changes to the firm's recall strategy, to its recall communication, and to its press release (if necessary).
FDA may inform a firm that a product violates the law, and discuss the possibility of a recall with a firm without specifically requesting a recall. Under these circumstances, a firm may decide to recall a product, and the firm's action is considered a firm-initiated recall. 21 CFR 7.46(c).
- Such discussions with a firm shall be conducted by: (1) the District Director or his or her designee, with the concurrence of the applicable Center's Director of the Office of Compliance or designee; or (2) the applicable Center's Director of the Office of Compliance or his or her designee, with the concurrence of the District Director or designee.
- This discussion may occur during oral communications with the applicable firm(s), the firm's US agent (for a foreign firm), or the firm's legal representative. The conversation with the firm should be documented in internal meeting minutes or notes, in accordance with Agency's procedures.
- If the firm does not initiate a recall of a violative product, the agency may consider further action such as public notification (e.g., to consumers, healthcare practitioners, etc.), an FDA-requested recall letter, or an FDA-mandated recall order, seizure, or injunction. As soon as practicable and when recall or cessation of distribution of a regulated product is appropriate to protect public health, the District, OEIO, and the applicable Center(s) shall collaborate and conduct an assessment to determine the strategy for any potential follow-up, to assess the risk and to determine whether if the potential recall would cause a shortage of a regulated product. The District should identify appropriate timeframes to accomplish these tasks, in consultation with the applicable Center(s), based on the degree of risk associated with the particular recall.
For firm initiated recalls, the agency will conduct a health hazard evaluation (HHE), (precedent HHEs or written classification policies may be used), will classify the recall, and will advise the firm in writing of the assigned recall classification. The letter to the firm will recommend any appropriate changes in the firm's recall strategy and advise the firm that its recall will be placed on the FDA web site. FDA will also assign audit checks as appropriate, will monitor the effectiveness of the recall communication, correction or removal, will verify appropriate product disposition, and will terminate the recall when appropriate.
- submits a Recall Alert;
- gathers information about the recall. It may conduct an establishment inspection and collect samples of the recalled or other suspect products;
- submits a Recall Recommendation and other information about the recalled product to the appropriate center;
- offers guidance to the recalling firm;
- monitors the recall; and,
- terminates Class II and III recalls and recommends termination for Class I recalls.
- Recall Alert
The district, as soon as possible, but preferably within 24 hours, after learning of a recall either planned or in progress, should notify the appropriate CRU and OEIO/DE Recall Operations Staff (HFC-210). The district should submit this Recall Alert through RES by completing, at a minimum, all the fields identified in Attachment A, and may submit any other information at the same time. Additionally, the district will scan and e-mail or fax to the CRU a copy of the recalling firm's recall communication and press release, if any. A copy of the press release is also to be forwarded to OEIO/DE and to the OPA Field Liaison. Alerts have not been required for device recalls under section 518(e), biologics recalls for which CBER issued an "alert to possible recall," and corrective action program (CAP) recalls involving radiation emitting medical devices and electronic products. These exemptions will continue under RES.
OEIO/DE will promptly notify the ACRA of significant recall actions and will provide copies of recall documents where appropriate.
- Recall Recommendation and Related Information
The district must submit a complete Recall Recommendation (RR) through RES within five working days after submitting the recall alert or as soon as the recalling firm has provided the information necessary for the RR. When the information is submitted through the RES system, it automatically alerts the appropriate CRU and OEIO/DE via e-mail. See Attachment B for guidance on the information required by the CRU to review and classify the recall. The district may submit the Recall Alert and Recommendation up to 10 working days after the district learns of a "completed" recall.
- In conjunction with the recall recommendation, the district will submit to the appropriate CRU, as soon as possible:
- legible copies of all labeling, including operations manuals, brochures, flyers, or any other product related literature that will aid in determining the violation and evaluation of the product problem;
- product specifications, formulation and related documents;
- FDA and/or state laboratory worksheets and/or the firm's pertinent quality control or analytical records for all products involved;
- if the district does not have a physical sample to demonstrate the defect and the potential hazard, other documentation of the justification for recall, such as a copy of the FDA-483 documenting serious violations of GMPs, or epidemiological evidence; and,
- if not previously submitted at time of the Alert, a copy of all of the recalling firm's communications to the CRU. For potential Class I recalls, also forward a copy to OEIO/DE.
This material should closely follow the submission of the RR and should be submitted by the fastest means possible, for example, by scan delivered via e- mail, by fax, or by guaranteed overnight delivery.
If there is insufficient information to submit an RR, the district recall coordinator should telephone or email the appropriate CRU and OEIO/DE for advice on a course of action.
- When requested by OEIO/DE or the CRU, 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 should recommend the action be designated as a market withdrawal since, although the situation may present a health hazard, there is no one identified as responsible for the violation. This will allow documentation and monitoring of the market withdrawal.
- FDA regulated products manufactured by U.S. firms for foreign distribution and which are in violation of United States laws will be processed, classified, and published the same manner as domestic recalls.
- FDA regulated products manufactured by foreign firms recalled in the U.S. will be processed, classified and published (including entered in RES) the same as products manufactured in the U.S. If the U.S. Agent initiates the recall on behalf of the foreign firm, the U.S. Agent gets copies of the FDA correspondence on the recall. However, if the US agent refuses (or, otherwise fails) to initiate the recall and the foreign firm performs the notification to its first line distributors, then the foreign firm is the recalling firm and receives the classification and termination letters from the ACRA, center or district.
- If the CRU or OEIO/DE finds the RR information lacking in any way, either may request that the district obtain the additional information. This may be done by telephone, email, or the electronic return of the recall record with comment.
- In conjunction with the recall recommendation, the district will submit to the appropriate CRU, as soon as possible:
- Establishment Inspection
The district will contact the firm to obtain recall information and, in the case of recalls that have been classified as or appear to be class I or significant class II recall situations, an establishment inspection should, in addition to other activities, determine the root causes of the problem and document violations for possible regulatory action If appropriate corrective action is not being implemented, and evaluate overall compliance. See the IOM Chapter 7 – Recall Activities for guidance in conducting recall related inspections.
The establishment inspection should, in addition to other activities:
- Obtain the recalling firm's proposed recall strategy [21 CFR 7.46(a)], if not previously submitted by the firm.
- Collect copies of all labeling associated with the product.
- Obtain complete distribution of all shipments of the suspect lot(s), including complete names and addresses of all foreign consignees.
- Obtain supporting documentation that will assist the agency in identifying and evaluating the problem such as product complaints, product specifications and test results, including the methods used to obtain the results.
- For medical device recalls, obtain marketing status of the device being recalled, that is, 510(k) or PMA number(s), or preamendment device with proof of status.
- Assess the root causes of the problem. Determine how and when the problem occurred and how and when it was discovered. Obtain the firm's corrective action to prevent future occurrences.
- Verbally apprise management that the district office should be consulted prior to the reconditioning or destruction of any returned product. Management should also be advised that FDA must witness or otherwise verify product disposition. Prior to initiating an establishment inspection, district personnel should determine whether similar complaints have been entered into FACTS. For devices, search CDRH's MAUDE database or contact CDRH's Division of Surveillance Systems, Information Analysis Branch (HFZ-531) to retrieve complaints. For drugs, contact CDER's Division of Compliance Risk Management and Surveillance, (HFD-330) 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.
In many recall situations, the firm's production facility may differ from the recalling facility, typically a headquarters or corporate office. In these cases, the monitoring district will contact the district where the violation occurred and request an inspection of the responsible establishment. The investigating district, in turn, should keep the monitoring district informed of the inspectional progress and findings.
Usually during this initial contact, the center has neither evaluated the health hazard nor classified the recall. In that case, the district office should not urge the firm to expand or reduce its recall efforts. In all discussions of violative or potentially violative products with the responsible firm, avoid any misunderstanding that FDA is formally requesting recall action. FDA requested recalls may be authorized only by the ACRA or by center directors delegated that authority.
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, process validation protocols and reports, signed destruction receipts, salesperson's written receipts, corporate official's signed statement on firm's stationery, etc. The district should update RES with the recommendation and termination information within 10 days of learning of the recall.
If the responsible firm is out of business or is unable to conduct an effective recall for any reason, the district should notify the CRU and OEIO/DE. The district and the CRU should develop an appropriate course of action to recommend to the ACRA. In significant situations involving a serious health hazard, this could involve issuance of press to notify the public and/or FDA notifying consignees directly.
- Official Samples
The district must determine the need for an official sample, either physical or documentary. Typically collect samples when they best demonstrate the defect and potential hazard. 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 CRU or OEIO/DE. Samples collected should document interstate movement as well as the violation.
- Firm Recall Communication and Notification
The FDA District Office Recall Coordinator should offer guidance to the recalling firm and will offer to review the text of recall communications to consignees so that the product will be promptly removed or corrected. The CRU and OEIO/DE staff are available, if necessary, to assist the District Office Recall Coordinator. Recall communications can be in multiple forms including press releases, telephone calls, telegrams, telefaxes, mailgrams, or first class letters. For tobacco products, the Center for Tobacco Products should be contacted for guidance on any recall communications and notifications submitted by the recalling firm.
The recalling firm should discuss any recall communications and notifications with the FDA District Office Recall Coordinator before issuance. The possible need for bilingual or multilingual communications should be explored between the FDA District Office Recall Coordinator and the firm.
All recall communications should be written in accordance with the following guidelines: be brief and to the point; clearly identify the product(s) such as the product name, size, brand name, serial numbers(s), potency, dosage, type, model, lot number(s), UPC codes, Unique Device Identifier (UDI) if applicable, and any other pertinent descriptive information to enable accurate and immediate identification of the product; contain a concise statement of the reason for the recall; state known or potential hazard(s), and instructions for consignees to follow in handling the recall. If possible, the recall letter may provide the initial shipping date and quantities shipped. See Exhibit 7-4 Model Recall Letter.
If a firm has voluntarily initiated a recall of any product(s), then it is responsible for promptly notifying each of its direct accounts. If the depth of the recall is beyond the direct accounts, then the direct accounts should be instructed by the recalling firm to contact sub-accounts that may have received the product.
Sub-accounts, which further distributed the product should continue the recall to the depth established in the recall strategy. A written recall communication to sub-accounts should be in addition to any other means of communication, such as monthly sales bulletins, manufacturer representative visits, or recorded phone messages. These actions may aid in a sub-recall effort, but they are an inadequate communication of the recall.
Ensure that the recalling firm conspicuously marks the outside (e.g. the envelope) and the enclosed information (e.g., the recall letter or other type of message) of the recall communication "DRUG (or FOOD, BIOLOGIC, MEDICAL DEVICE, TOBACCO PRODUCTS, etc.) RECALL (or CORRECTION)." Additionally, the outside and enclosed information should be marked "URGENT" for all Class I and Class II recalls, and, when appropriate, for Class III recalls.
Recall communications should be sent in the most expeditious manner and commensurate with the hazard of the product being recalled, and, where appropriate, sent with proof of receipt (e.g., by certified mail). All communication methods related to the firm's recall should be documented accordingly.
Recall communication, particularly 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 its disposition. Recall communications should direct that the consignee submit a report regardless of whether or not any of the products are on hand. It should also stress prompt return of the post card or other report. (See Exhibits 7-4, 7-5, 7-6, 7- 7, FDA Recall Industry Guidance webpage for model letters, envelopes, and recall return response forms.)
This section only applies to FDA requested recalls in accordance with 21 CFR 7.45. An FDA request that a firm recall a product is ordinarily reserved for urgent situations. The request is directed to the firm that has primary responsibility for the manufacture or marketing of the product when the responsible firm does not undertake a product recall on its own initiative. FDA requested recalls are most often classified as Class I. Generally, before FDA formally requests recall action, the agency will have evidence capable of supporting legal action, i.e. seizure. Exceptions include situations where there exists a real or potential danger to health, or in emergency circumstances such as outbreak of disease involving epidemiological findings. The completion of either a firm initiated or FDA requested recall does not preclude FDA from taking further regulatory action against a responsible firm.
The Associate Commissioner for Regulatory Affairs (ACRA) approves all FDA requests for firms to conduct recalls. except that in some cases certain center officials are also authorized to approve FDA requested recalls (see SMG 1410.412).
FDA requested recalls may begin with various communications between the field and headquarters units, but will implemented by submitting an Alert and a FDA Requested Recall Recommendation in RES in the same manner as for voluntarily initiated recalls. All data and documentation related to the problem, as indicated above under the Recall Recommendation and the Establishment Inspection paragraphs, will be obtained and submitted to the CRU. The CRU will process the recommendation as outlined in the following paragraphs on Recall Classification and Strategy and submit an Action Memorandum to the ACRA through OEIO/DE.
OEIO will review the Action Memorandum and promptly prepare and forward a recommendation to the ACRA.
If the center's recommendation is approved by the ACRA and the letter to the recalling firm signed, the ACRA or his/her designee will notify the firm by letter of FDA's determination of the need to immediately begin a recall. The letter will specify the violation(s), health hazard involved, and recommended recall strategy. It will provide any other instructions appropriate to effectively conduct the recall.
When the district receives a copy of the letter sent to the responsible firm by the ACRA, district personnel should verify the firm's receipt of the letter and make arrangements to visit and/or 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 situations.
The district office will offer the same guidance to the recalling firm as outlined above and will assist the firm in arranging the text of recall communications to consignees so that the product will be promptly removed or corrected.
Various sections of the law authorize FDA to order a firm to recall a product. Each is discussed separately below. If the recall is FDA ordered, the agency will issue a written order to the firm to recall. This order should state the violation and the section of the Act or regulations 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.
FDA ordered recalls often have timeframes and procedures specified by regulation. The district should familiarize themselves with these before proceeding with assistance to the firm. The center compliance office normally takes the lead in negotiations with firms on FDA ordered recalls. The district should plan its strategy with direction from the center.
- Mandatory Device Recalls
Under Section 518(e) of the Act, 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 has the authority to order the manufacturer, importer, distributor, retailer, or any appropriate person to immediately cease distribution of the device, 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. The Secretary delegated the authority to issue Section 518(e) orders to the Center Directors and Deputy Center 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 (21 CFR 5.411). Such orders must have the concurrence of the Office of Chief Counsel (see procedures in Attachment G). The implementing regulations are found in 21 CFR 810. After giving the party subject to the order an opportunity for a regulatory hearing, FDA must either vacate the order or amend it to include a recall of the device.
SMG 1410.412 indicates that, for medical devices assigned to their respective organizations, the Director, Deputy Director, and certain other officials, in CDRH, CDER and CBER, are authorized to perform all of the recall functions under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360h(e)), that have been delegated to the Commissioner. In those cases, the center director is responsible for appropriately advising the ACRA. In all cases of FDA requested recalls, the center director must concur with Action Memoranda required to be submitted to the ACRA.
- Mandatory Recall of Biological Products
The National Childhood Vaccine Injury Act of 1986 amended the Public Health Service Act (PHS Act) to provide recall authority for biological products (42 U.S.C. 262). If a determination is made that a batch, lot, or other quantity of a product licensed under the PHS Act presents an imminent or substantial hazard to the public health, the Secretary has the authority to issue an order for its immediate recall.
- Mandatory Recall of Human Tissue Intended for Transplantation
On November 21, 2004, FDA issued regulations requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; record keeping; and the establishment of a quality program (GTP final rule 69 FR 68612). FDA promulgated the new regulations under the legal authority of section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264). The regulations at 21 CFR 1271.440 include a provision for orders of retention, recall, and/or destruction, and a new provision for orders of cessation of manufacturing in certain circumstances. Such orders are intended for use in situations when needed to prevent the introduction, transmission, or spread of communicable diseases. HCT/Ps subject to the provisions in 21 CFR 1271.440 include, but are not limited to bone, ligaments, skin, dura mater, heart valves, corneas, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen and other reproductive tissue. The regulations at 21 CFR 1271.440 do not apply to vascularized organs such as livers, hearts, and kidneys, human milk or any tissues currently regulated by FDA as human drugs, medical devices , or licensed biological products. See RPM Chapter 5, Order of Retention, Recall, Destruction, and Cessation of Manufacturing Related to Human Cell, Tissue, Cellular and Tissue-Based Products (HCT/Ps), for detailed procedures.
- Infant Formula
The Infant Formula Act of 1980 and its 1986 amendments mandate that an infant formula manufacturer promptly notify the Secretary if the manufacturer has knowledge that reasonably supports the conclusion that an infant formula shipment may not provide the required nutrients or may be otherwise adulterated or misbranded.
If the Secretary determines that the infant formula presents a risk to human health, the manufacturer must immediately recall shipments. It is a prohibited act [Section 301(s)] for a manufacturer of infant formula who engages in a recall to fail to request that retailers post notice of recall for a length of time specified by the Secretary and to 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 21 CFR, Part 107, Subpart E.
- Tobacco Products
Under Sections 908(a) and 908(c) of the Act, if the agency finds that there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the agency shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. The order shall provide the person subject to the order with an opportunity for an informal hearing on the actions required by the order and on whether the order should be amended to require a recall of such tobacco products. After providing an opportunity for a hearing, FDA must vacate the order if inadequate grounds exist to support the actions required by the order.
- Mandatory Food Recalls
FDA will exercise its authority under section 423(a) of the Act and provide a responsible party (as defined in section 417 of the Act) an opportunity to voluntarily cease distribution and recall a food when FDA has determined that there is a reasonable probability that the article of food (other than infant formula) is adulterated under section 402 of the Act or misbranded under section 403(w) of the Act and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals (SAHCODHA).
FDA may exercise its authority to mandate a recall under section 423(b)-(d) if FDA has provided the responsible party with an opportunity to voluntarily cease distribution or recall the article of food; and the responsible party has refused to or has not voluntarily ceased distribution or recalled the article of food within the time and manner prescribed, if so prescribed, by FDA.