Managing corrective and preventive action (CAPA) activities is a perennial problem for device manufacturers. Complaints, nonconformances, out-of-specification results all should generate a CAPA file, but the FDA continues to find fault with the way they are handled. Chances are, if you received a 483 at your last inspection, the words “corrective action” appeared prominently on the form. If they did, was your response detailed and specific enough to satisfy the FDA?
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