What To Expect When They're Inspecting – Part II

By Holly Scott, Senior Consultant, Biologics Consulting Group, Inc.

The first segment of this series focused on some of the nontraditional variables that can have an effect on any FDA inspection, and how to achieve a positive outcome regardless of the inspectional conclusion. That article generated some blog discussion on FDA’s objectivity. I wanted to clarify some of those issues. FDA Investigators are trained to be objective in all situations and will approach their inspection in this manner. However, firm management needs to understand that when intentional barriers to an effective inspection are presented, or the FDA Investigator is met with a less-than-cooperative attitude, the realistic conclusion is that management is trying to hide objectionable GMP conditions — leaving the investigator no choice but to be even more thorough to ensure there are no safety or quality risks to the consumer. It isn’t that an FDA Investigator is showing bias or being subjective, they’re “investigators” – it’s their job to do so.

Does an uncooperative management affect the neutrality of an investigator performing an inspection, or cause the firm to receive any unwarranted FDA-483 citations? Absolutely not! Can it result in a more thorough inspection, causing FDA to review functional areas not originally intended because of attempts by management to stall, withhold, or obstruct FDA from conducting an effective inspection? Of course it can, but it doesn’t mean any deviations noted on the FDA-483 are unjustified.

When I discuss aspects of FDA inspections and the ways in which firm management can influence the outcomes, I simply want firms to be aware of the possible impact of their decisions, whether the result is positive or negative. It isn’t subjectivity and it isn’t personal, its reality. Hopefully, this will provide a clear postscript to Part I.

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. 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.