Compliance Advice: Dispelling Myths of Corrective Action Systems

Posted 01 July 2008 | By

I am confused about the results of an FDA inspection of our medical device facility. The investigator issued an FDA Form 483 citing our approach to corrective and preventive actions (CAPA). We have not established a formal CAPA program because we are a small company, but I believe we address all CAPA requirements.

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