Are you prepared for a random FDA audit? The United States Food and Drug Administration often announces their plans to audit your company at the last minute. With only a few days’ notice, what should you do first to prepare for an FDA inspection? And what can you expect once the investigator arrives?
FDA QSR inspections don’t have to be as dramatic as they sound. Preparation, planning, and clear expectations will make your next FDA audit less stressful, and you might even pass with flying colors. This paper describes exactly what to expect from an FDA audit and how to prepare for the inspector's imminent arrival in a concise, at-a-glance checklist. What you will learn in this 8-page white paper:
- How to prepare for an on-site audit (FDA Audit checklist).
- What happens during the inspection?
- How is an FDA audit structured?
- What is the most effective way to ensure a successful FDA inspection?
- What is an exit/closing meeting?
- How and when to address inspection observations or Form 483 Warning Letters?
About the Author
Richard Vincins, CBA, CQA, RAC (US/EU) is Vice President, Quality Assurance Consulting at Emergo. With over 25 years of experience in the medical device industry, Richard's areas of expertise include ISO 13485, US FDA QSR, and many other country quality system implementations including Canada, Japan, Brazil. Additional areas of expertise include US FD A 510(k) registration, European CE Marking, multiple country product registrations, risk management, and clinical investigations. Richard's main focus and responsibilities are advising compliance of medical device and IVD companies to the ever expanding regulatory requirements.