Steps to evaluate the progress of an FDA recall

Once a Food and Drug Administration recall is initiated, a company is responsible for evaluating the progress of the recall of the medical device, drug, biological product, or package, and providing routine updates to the FDA. The three parts of a recall evaluation include the following: 1. An effectiveness check is necessary to verify that the notification letter was received by the customer and that the recalled product has been handled appropriately. For more information, see methods for conducting recall effectiveness checks. 2. A recall status report is routinely provided to the local FDA district recall coordinator. One of the components of the status report is the determination of the root cause. In addition, the report includes the number of customers notified and the customer responses. 3. In order to terminate the recall, all product possible must be recovered. Once this occurs and the disposition of the recalled product has been completed, a final status report can be generated.

More detailed information on the regulations, guidance, effectiveness check letters, and enforcement reports is available on the FDA's recall Web page.

--By Linda McBride, Registered Pharmacist

Linda McBride is the director, regulatory affairs for Medi-Flex, Inc. Her 16 years of pharmaceutical industry experience include positions with Bayer HealthCare, Oread, and Novartis Consumer Health. She holds a B.S. in pharmacy and is a member of the International Society for Pharmaceutical Engineering and the Regulatory Affairs Professionals Society.
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