FDA Offers Tips on What Triggers Inspections

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Clinical trial sponsors, clinical investigators, and institutional review boards often struggle to understand what most often triggers a U.S. Food and Drug Administration (FDA) inspection—especially one that is unannounced.

The prospect of an unannounced FDA inspection can loom over a clinical trial site. While the vast majority of inspections are prescheduled, FDA is more likely to arrive without warning if the inspection was assigned as a result of information that raises concern about the site, such as about the adequacy of its subject protection measures, or issues with data integrity, and/or a history of problems with the inspected party, FDA officials say.

FDA inspections of entities involved in clinical trials are considered bioresearch monitoring (BIMO) inspections, to differentiate them from the manufacturing inspections more commonly conducted by FDA inspectors. FDA BIMO inspections are usually preannounced.

In most cases, the FDA investigator contacts the site and suggests a date for the inspection, rather than offering to schedule it. This usually occurs about five days prior to the date the FDA investigator has chosen to start the inspection. In other words, they won’t call until they’re about ready to move.

FDA will work with the inspected party—up to a point. “If there are extenuating circumstances—for example, if all of the staff will be attending a professional conference in the next week—an adjustment of the inspection dates can be made,” says Doreen M. Kezer, MSN, a senior health policy analyst with the Office of Good Clinical Practice in the Office of the Commissioner for FDA.

“Continued attempts to postpone an inspection will be considered a refusal of inspection, which is a serious violation,” Kezer adds. For example, FDA can obtain a warrant to inspect if the inspection is refused.

For more resources on this topic, see FDA’s Compliance Program Guidance Manuals. For feedback on specific questions, reach out to the agency at gcp.questions@fda.hhs.gov.

Author: Michael Causey