FDA pre-approval inspection checklist

Use this checklist as a training tool by conducting mock inspections where team members practice answering questions about their areas of responsibility. Focus on clear communication, providing only what’s asked, and knowing when to defer to subject matter experts. The checklist helps identify knowledge gaps that can be addressed before FDA investigators arrive.

Have your standard operating procedures, validation protocols, batch records, deviation reports, CAPA documentation, and training records organized and accessible. Verify that these documents are not only available but also complete, accurate, and aligned with what was submitted in your drug application.

Document each deficiency, assess its risk level, and develop a corrective action plan with clear ownership and timelines. Prioritize issues that could impact product quality or patient safety. The checklist serves as your roadmap for systematic improvement, helping you track progress toward full compliance before the inspection.