Medical Device Recall Checklist

This checklist outlines key considerations for recalls of medical device products regulated by the U.S. Food and Drug Administration (FDA).

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• Pharmaceutical Manufacturing and Supply Chains
  Understand the registration of pharmaceutical manufacturers with the FDA, the role of pharmaceutical manufacturers in the supply chain, and related regulatory enforcement issues.

• Quality Agreement for Drug Product Manufacturing
  Draft and negotiate a drug product manufacturing arrangement between a drug company and a contract manufacturing facility.   

• FDA Warning Letters Tracker
  Monitor warning letters issued by the FDA in response to FDA’s determination that a manufacturer has violated, or potentially violated, applicable requirements of the Food, Drug, and Cosmetics Act (FDCA).

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