What to Expect During an FDA Inspection and How to Prepare

Summary

Enhanced Compliance Inc. is releasing this white paper to better inform the medical device industry about what to expect from the FDA during an inspection and how to prepare for such an event. It also addresses what not to do during an FDA inspection. This white paper is divided into three main parts: 1. FDA Expectations during an inspection, 2. Preparation for an inspection and the appropriate “do’s”, and 3. What not to do during an inspection. It is imperative that a firm be ready for the FDA to enter their facilities to conduct an inspection at any reasonable time. Readiness for the inspection together with appropriate preparation for what the FDA may be looking for and what they may review is critical to a successful engagement with the Agency.