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Does FDA expect firms to investigate both released and rejected lots for potential recalls?

17/09/2021 | 1077

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Reply:

Yes. 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

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