Inspections, Compliance, Enforcement, and Criminal Investigations



7-6-1 - Health Hazard Evaluation
7-6-2 - Classification Process
7-6-3 - Classification Notification And Routing
7-6-4 - Recall Strategy


The Center Recall Unit (CRU):

  1. initiates a health hazard evaluation;
  2. finalizes a recall strategy;
  3. determines that the firm’s action is a recall, classifies the recall, and, for Class I recalls not delegated to the center, prepares an Action Memorandum for Center Director or his/her designee concurrence before forwarding it to OEIO/DE and the ACRA; and,
  4. updates RES with classification, audit strategy, and any recommendations.

7-6-1 - Health Hazard Evaluation

The agency will conduct or obtain health hazard evaluations (HHE) for each recall scenario. Precedent HHEs will be used where the product is identical or similar with basically the same defect or violation as a recall action previously classified. Precedent HHEs will be re-evaluated and updated periodically. Established precedent recall policies such as those established by CDRH may also be used.

Upon receipt of each recall recommendation or other information, from any source, which indicates a recall may be necessary, the CRU determines whether an up-to-date health hazard precedent exists covering the situation. If not, it forwards the appropriate information to the Center Health Hazard Evaluation Committee for review. Additional information received during the progress of a recall should also be forwarded to the committee for timely health hazard reevaluation.

The Health Hazard Evaluation Committee in each center should use the Health Hazard Evaluation Worksheet (Attachment D) to record their evaluations. This evaluation will take into account the factors listed in 21 CFR 7.41(a) and Attachment D1 of this chapter. The health hazard evaluation form must be prepared by knowledgeable center personnel and should reflect their written concurrence. The HHE committee may use a precedent health hazard evaluation in lieu of conducting a new HHE for a similar situation. It is the responsibility of the HHE Committee to ensure itself that all reviewers are familiar with the intent of the evaluation.

The HHE Committee will complete, endorse, and forward the health hazard evaluation form to the center recall unit within two (2) working days after receiving a recall recommendation unless additional information is required. It is the responsibility of the HHE Committee to notify the CRU when further information is needed. If the recall recommendation indicates that the product is no longer in distribution channels, they will complete, endorse, and forward the HHE to the CRU within five (5) working days.

The Health Hazard Evaluation Committee must promptly reevaluate the initial health hazard when additional data regarding injury, illness, medical, or scientific findings is received by the center. Where additional data are being received on a continuing basis, the committee is to routinely meet and reevaluate the health hazard at least biweekly.

The CRU should coordinate their review with other centers when necessary. Any questions about lead center responsibility or jurisdiction should be promptly referred to OEIO/DE.

7-6-2 - Classification Process

For ongoing recalls, the CRU will normally classify recalls within two days after receiving the health hazard evaluation or confirming the classification through precedent review. As appropriate, before classifying a recall, the CRU may make a determination that the action is a recall under the applicable definition of a recall. They will add classification information to the recall document in RES and transmit the classification electronically to the monitoring district and OEIO/DE.

The CRU will then review, correct, edit or add information necessary in the RES public information fields prior to posting to the Enforcement Report.

The ACRA has approval authority for all Class I recalls. However, the ACRA has delegated approval of certain Class I recalls to center directors. This has been done to streamline the recall classification process in the center, expedite the handling of the recall by industry and FDA district offices, and in certain situations, to have it universally understood that these recalls represent potentially serious to life-threatening health hazards. The center director may further delegate within the center compliance office the authority for review and classification of recall actions previously established by the ACRA as Class I. Specifically, for CFSAN, this includes precedent situations such as Listeria monocytogenes, salmonella species, various allergens, and pathogens in ready to eat foods.

The CRU will prepare the recall Action Memorandum in all situations requiring ACRA or center director approval. Attach copies of the following: health hazard evaluation, the firm's or FDA's recommended recall strategy, FDA audit program, and the initial recall recommendation. As appropriate, attach product analytical results, medical records, evaluations, etc., which are pertinent to the hazard evaluation and subsequent recall classification. In the case of FDA requested recalls, propose a course of action in the memorandum to be taken if the firm elects not to recall. Submit the Action Memorandum to the center’s compliance director for review and concurrence in all Class I recall recommendations prior to submission to the center director. The center director approves all Action Memoranda required to be submitted to the ACRA for concurrence with Class I recommendations and FDA requested recalls.

OEIO/DE may review the Action Memo and discuss it with the CRU before submitting it to the ACRA. When the center and ORA/OEIO disagree on aspects of a recall or when the ACRA believes the health hazard evaluation or recall classification warrants additional medical review, OEIO/DE may request that an ad hoc committee be formed to review and recommend changes to the health hazard evaluation or recall classification.

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 within five calendar days.

The CRU may classify Class II and III recalls without management review. However, unusual and/or potentially high profile recall issues should be brought to center management’s attention.

7-6-3 - Classification Notification And Routing

When the ACRA approves the Recall Action Memorandum, the center and the district office are informed by OEIO/DE (via e-mail) of the ACRA's decision. The classification letter when signed by the ACRA will be mailed to the firm by DE. Distribution copies of the final approved documents will be sent to the center and the district office 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.

When the CRU receives the ACRA approved Action Memorandum and letter to the recalling firm, the CRU will update the RES recall application, including the center Internet Release page. The classification information is then transmitted to the district and OEIO/DE.

7-6-4 - Recall Strategy

Each recall is unique and requires its own recall strategy. The CRU will review the firm's recall strategy for voluntary recalls and will develop a strategy for FDA requested recalls. The recall strategy includes the type of notification and depth of the recall. It also contains the depth and level of audit checks and the need for public warning. Recall strategies are based on the individual recall circumstances and are not necessarily dependent on the recall classification.

For FDA requested recalls, the center’s compliance director ensures that the regulatory strategy cited in the recall recommendation and the action memorandum is supportable in the event the firm refuses the ACRA’s request to recall or fails to complete the recall effectively or in a timely manner.

If the agency approves an industry Corrective Action Program (CAP) for a radiation emitting electronic product, the agency will notify the responsible firm that its CAP is classified as a recall and will stress the need for prompt corrective action. These corrective actions are taken to correct either product defects or non-compliance with standards. (See Attachment E, Recalls of Radiation Emitting Electronic Products).

  1. Elements of a Recall Strategy

    As specified in 21 CFR 7.42(b), a recall strategy should include a statement on and the reasons for recommending the desired option under each of the following elements:

    1. Depth of recall. The recall may extend to the consumer or user level, the retail level, or the wholesale level.
    2. Public warning. In urgent situations, consideration should be given to the need for a press release that could be nationwide or to affected geographical areas only. In some cases, special communication with specific segments of the population (e.g., physicians, pharmacists, veterinarians, and hospitals) may be appropriate. When the CRU believes that there is a need for a FDA press release or a Talk Paper, in addition to the FDA Recalls web page posting, they should coordinate with the appropriate press officer on OPA’s Media Relations Staff (HFI-20). Similar Information may also be posted on Med Watch.
    3. Effectiveness Check Level. This includes the method(s) to be used for and depth of recall effectiveness checks.

    The recall strategy should consider the disposition of recalled products (e.g., carcinogenic products) when normal disposition means, landfill, crushing, denaturing, etc., are inadequate.

  2. Recall Strategy Review or Development

    In reviewing or developing a recall strategy, the CRU should take into account the health hazard evaluation, type or use of the product, 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, distribution pattern, validated salvage or rework plan, and the continued availability of essential products.

    For firm initiated recalls the CRU will review and change as indicated or concur with the firm's recall strategy and the district's recommendations for the FDA audit program. For firm initiated recalls, center coordinators should obtain current assessment of recall effectiveness from the field. The center will communicate recommended changes in the firm’s recall strategy and effectiveness checks and the FDA audit program to the District Recall Coordinator and OEIO/DE and update RES.

    For FDA requested recalls the CRU will develop a recall strategy and include it in the center’s Action Memo.

    FDA may have to conduct the recall when a responsible firm is out of business or is unable to conduct a recall for any reason. The CRU, working with the involved district, will consult with OEIO/DE about strategy to implement recall action by FDA.

    The CRU, when necessary, will develop an interim strategy 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, and for device recalls requiring replacement of components or software that must be developed.

    The interim strategy will indicate the immediate actions to be taken on the part of the responsible firm to ensure 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. The District Recall Coordinator and the CRU should discuss any corrections/modifications to the recall strategy, as necessary, for follow-up and correction by the recalling firm PRIOR to completing the recall classification in RES. If these corrections are not made prior to classification, the recalling firm may interpret the center’s classification as acceptance of their inappropriate recall strategy.

Page Last Updated: 06/19/2015
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