With the passage of the Food Safety Modernization Act (FSMA), preparing for your next FDA inspection may seem a bit daunting. FDA is working aggressively to overhaul the safety of the nation’s food supply, and is now enforcing its new rules during routine inspections. During these visits, FDA is conducting lengthy facility inspections, comprehensive records reviews, and intense microbiological sampling of ingredients, finished products, and the food processing environment. Within the coming years, FDA Investigators will conduct an onsite inspection of every registered food facility within the U.S.
Working for nearly two decades as FDA lawyers, we are pleased to provide the following FDA Inspection Checklist to help you complete the needed preparations before the FDA Investigators arrive, to help navigate the process once the inspection has begun, and to appropriately respond to any FDA criticisms once the inspection concludes. With FDA’s aggressive food safety enforcement posture, it is now more important than ever to be prepared.