5 Keys to Passing an FDA Inspection or Audit

 Among its many federal mandates, the U.S. Food and Drug Administration (FDA) is responsible for helping to ensure that unsafe foods, medications, and other products do not make their way into consumers’ hands. One of the ways it fulfills this responsibility is by conducting inspections and audits of manufacturers’ facilities.

For manufacturers, an FDA inspection audit is a key step in the approval process—and failing an inspection or audit can set a company’s go-to-market strategy back by months, if not years. If a company isn’t prepared to meet the FDA’s requirements, learning this during an inspection or audit could lead to shuttering the company’s operations altogether.

When conducting inspections and audits, FDA agents go by the agency’s Investigations Operations Manual. This is a 541-page tome (as of 2021) filled with voluminous and highly-technical specifications and requirements. The chapter on Establishment Inspections is 137 pages on its own and covers walk-through inspections, federal labeling laws, and everything in between. 

As a result, passing an FDA audit inspection is not an easy process. Rather than simply letting FDA agents roam their facilities and inspect their files, companies need to prepare thoroughly, and they need to play an active role in the inspection or audit process.

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