What to Expect When They're Inspecting: Part I

FDA 101: Fundamentals That Can Influence The Outcome Of An FDA Inspection

By Holly Scott, Senior Consultant, Biologics Consulting Group, and former CBER Consumer Safety Officer and FDA Field Investigator

The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. More than likely, everybody will describe a different inspection experience and no two perceptions will be the same.

One expects variations in the level of coverage at firms in different program areas, whether it’s drugs, devices, biologics, dietary supplements, clinical research, or a food firm, because each industry area is so technically diverse. However, observation methods used by investigators should be comparable, and not diverge significantly. If two firms are manufacturing the same regulated product, and both are undergoing a routine GMP inspection, why does one receive an FDA-483 citation for an observed deficiency, yet the second firm receives no citation for the same observation? Is it a lack of continuity between investigators, or are there other contributing factors?

The inspectional conclusion can often be impacted by how firm officials are handling the inspection and, in some cases, can be the difference between receiving an FDA-483 or not. You might say these are the unwritten subjective elements of an inspection. So, what are some of the non-GMP variables that can influence the inspection result and how should you approach the inspection to improve the outcome?

About The Author:
Holly joined BCG in September 2009 as a Senior Consultant. She brings approximately 19 years of multi-office experience with the Food and Drug Administration, including 4 years as a Consumer Safety Officer with FDA/CBER, and 15 years as a Field Investigator with the FDA Office of Regulatory Affairs/ Florida District Office. As a Senior Field Investigator, she was also responsible for the training of new field personnel and development of district procedures. Holly uses this experience to assist clients with compliance analysis, GMP audits, and regulatory support in all of these FDA-regulated areas.