7-3 - SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES

The FDA recall program gives recalls the proper attention at all levels of the agency and provides adequate resources to process, to classify, and to publicize recalls in a timely manner. FDA responsibilities are summarized below. This chapter is arranged according to the following outline:

1. Initiation of a Recall. Includes voluntary, FDA requested, and FDA mandated.
2. Classification and Strategy. FDA formalizes the recall action by reviewing the information, including the recall strategy provided by the firm, assessing the health hazard presented by the recalled product, and classifying the recall.
3. Notification and Public Warning. FDA notifies the firm of the classification and necessary changes in its recall strategy, including the need for press releases for those recalls conducted voluntarily. The agency notifies the firm of FDA requested or mandated recalls and the need for publicity. FDA publishes all recalls on the FDA Internet site and ensures that the public is warned about products that are hazardous to health. FDA provides recall information to other federal and state government agencies and to foreign governments.
4. Monitoring and Auditing the Recall. FDA develops and implements a recall audit program to ensure that the recall action has been effective.
5. Termination of a Recall. FDA determines when a recall should be terminated and, upon such determination, provides written notification of termination to the recalling firm.

Finally, FDA will take appropriate regulatory action or other measures when the firm fails to recall violative product or when a recall action fails. These actions will be taken in consultation and coordination with the district compliance branch, the appropriate center recall and compliance staffs, OE/DCMO, and when indicated, the Office of Chief Counsel, when:

1. a firm refuses to recall or sub-recall after being requested to do so by the FDA;
2. a firm fails to complete a recall in a timely fashion; and,
3. the agency has reason to believe that a recall strategy is not effective

7-3-1 - Responsibilities Of The Office Of Enforcement/Division Of Compliance Operations And Management (HFC-210)

OE/DCMO is the agency’s headquarters contact and focal point for information, advice, and direction for field recall operations and remains involved with each recall throughout its process. If required, OE/DCMO may direct appropriate follow up actions by the field. OE/DCMO, with the district coordinators and Center Recall Unit (CRU) evaluates firms’ recall performance. The recall staff encourages timely district and industry action on recalls. In the case of FDA requested recalls, as well as all Class I recalls for which the ACRA has not delegated classification authority to center directors, OE/DCMO is the liaison between the districts, the CRUs and the ACRA. The recall staff reviews and makes recommendations to the ACRA regarding concurrence with the Action Memoranda. OE/DCMO will forward its recommendation to the ACRA within one working day unless additional or supplemental review of the health hazard evaluation or recall classification or status is required. OE/DCMO periodically reviews all agency recall activities to ensure that current policy and procedures are being applied to recalls and recommends changes as appropriate. OE/DCMO evaluates the overall effectiveness of recall activities. OE/DCMO communicates trends, common causes of recalls, control weakness, etc., to units having the need for this information.

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7-3-2 - Responsibilities And Procedures – Office Of Enforcement/Division Of Compliance Policy (HFC-230)

OE/DCP reviews and resolves compliance policy issues related to recalls. The division reviews recall action memorandums when requested by OE/DCMO, particularly when a policy issue has been identified. OE/DCP provides written response to OE/DCMO.

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