How to passing an FDA inspection or audit?

 Make Sure You Know What the FDA Will Be Looking For

In “What should I expect during an inspection?”, the FDA emphasizes the importance of learning as much as possible about the inspection process. As it states, rather bluntly, “It is in your best interest to fully understand FDA's inspection procedures.” So, what are FDA agents going to be looking for? Equally important, how are they going to look for it? In order to answer these questions, it is necessary to take a deep dive into the FDA’s Investigations Operations Manual and the relevant Inspection Guide. 

As a baseline, the goal during an FDA inspection or audit is to demonstrate compliance. The FDA doesn’t expect more, and going above and beyond in one area is not going to make up for compliance deficiencies in another. Passing an inspection or audit requires compliance across the board—and, crucially, the ability to demonstrate compliance with appropriate documentation. 

While establishing (and documenting) compliance with regard to certain obligations is fairly straightforward, there are lots of issues that require careful attention to detail and an approach that specifically takes the company’s compliance obligations into account. This includes various general obligations and obligations that apply to specific types of products, drugs, and devices.

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