FDA publishes Q&As on Drug Recalls

The FDA recently published a set on Q&As on recall procedures in the section Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Holding and Distribution. To get to the Q&As please go here.

Recalls are actions taken by a firm to remove from the market any product that is in violation of laws administered by the FDA. Recalls of a drug may be conducted on a firm's own initiative or by FDA request. However it is said that FDA does not have authority to mandate a recall of a human drug, but it can take more authoritative legal actions against manufacturers that persist in marketing a defective product, such as seizure and injunction.

FDA expects that a firm will voluntarily recall a drug that is defective or flawed if it could be hazardous to health. Seizure, multiple seizure, or other court action is indicated when a firm refuses to undertake a recall requested by the FDA, or where the agency has reason to believe that a recall would not be effective, determines that a recall is ineffective, or discovers that a violation is continuing.

The FDA also expects firms to investigate both released and rejected lots for potential recalls. Under 21 CFR 211.180(e), manufacturers must establish and follow written procedures for periodically reviewing complaints, recalls, returned or salvaged drug products, and investigations of product discrepancies. Firms must also review an appropriate number of batches, whether approved or rejected, and, where applicable, records associated with the batches, to ensure that all potentially affected product is thoroughly investigated and appropriate follow-up action is taken [21 CFR 211.192].

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