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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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7-3 - SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES

 7-3 - SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES
      7-3-1 - Responsibilities of the Office Of Enforcement and Import Operations/Division Of Enforcement (HFC-210)
      7-3-2 - Responsibilities and Procedures – ORA/Office of Policy and Risk Management (HFC-230)
      7-3-3 - Responsibilities and Procedures – Office of Enforcement and Import Operations/Division of Compliance Systems/Enforcement Systems Branch (HFC-240)

  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. Determination that the Action is a Recall; Strategy; Classification. FDA formalizes the recall action by determining that the action meets the definition of a recall under 21 CFR 7.3(g)2 or the applicable definitions for recalls conducted under different regulatory or statutory authorities. FDA reviews the information, including the recall strategy provided by the firm, assesses the health hazard presented by the recalled product, and classifies the recall in accordance with 21 CFR 7.41.
  3. Notification and Public Warning. FDA notifies the firm of necessary changes in its recall strategy, including the need for press releases, and the classification of the recall. The Agency may issue its own press release announcing a firm’s recall. For food recalls conducted under Section 423 of the Act (as amended by Section 206 of the FDA Food Safety Modernization Act (FSMA), FDA ensures that a press release is published regarding the recall, as well as alerts and public notices; as appropriate under section 423(g) of the Act. FDA posts information about recalls on the FDA’s Internet site www.fda.gov. FDA provides certain 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 may take appropriate regulatory action or other measures when the firm fails to recall violative product or when a recall action fails. Regulatory actions will be taken in consultation and coordination with the district compliance branch, the appropriate center recall and compliance staffs, OEIO/DE, and when indicated, the Office of Chief Counsel, when:

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

7-3-1 Responsibilities of the Office Of Enforcement and Import Operations/Division Of Enforcement (HFC-210)

OEIO/DE 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, OEIO/DE may direct appropriate follow up actions by the field. OEIO/DE, 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, OEIO/DE 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. OEIO/DE 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. OEIO/DE periodically reviews all agency recall activities to ensure that current policy and procedures are being applied to recalls and recommends changes as appropriate. OEIO/DE informs OEIO/ DCS/ESB (Division of Compliance Systems/Enforcement Systems Branch) of recalls that may affect government agencies, and, in turn, OEIO/DCS/ESB informs the appropriate government agencies of such recall information, when applicable. OEIO/DE evaluates the overall effectiveness of recall activities. OEIO/DE communicates trends, common causes of recalls, control weakness, etc., to units having the need for this information.

7-3-2 Responsibilities and Procedures – ORA/Office of Policy and Risk Management (HFC-230)

OPRM develops, coordinates, and reviews compliance policies and regulatory procedures that can relate to recalls. The office will review recall action memorandums if requested by OEIO/DE, particularly when a policy issue has been identified. OPRM will provide a written response to OEIO/DE.

7-3-3 Responsibilities and Procedures – Office of Enforcement and Import Operations/Division of Compliance Systems/Enforcement Systems Branch (HFC-240)

OEIO/DCS/ESB receives recall information from DE when the identified consignees include government agencies. DCS/ESB forwards the information, as appropriate, to the applicable government agencies. Such sharing of information supports the Government-Wide Quality Assurance Program (GWQAP). DCS/ESB prepares the weekly Enforcement Report from ORA’s reporting system, works with the Center recall contacts to modify the report as necessary and published the report to FDA’s website.

 

 

2  As defined in 21 CFR 7.3(g), “Recall means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or stock recovery.” As defined in 21 CFR 7.3(j), “Market withdrawal means a firm’s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the Food and Drug Administration or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.”