FDA Inspections

Overview

When a Principal Investigator (PI) is notified by the Food and Drug Administration (FDA) that one or more of their clinical trials will be inspected/audited, this page includes resources to help comply with regulatory and institutional responsibilities.

Overview of the FDA inspection process.

Step1

Notification of the FDA inspection.

The steps the Principal Investigator (PI) of an FDA-regulated clinical trial should take when they are contacted by FDA about an upcoming inspection.

Notification Procedures

Step2

Before the FDA inspection.

Principal Investigators and study teams should follow these steps to prepare for the FDA Inspector's arrival.

Preparing for the FDA Inspection

Step3

During the FDA inspection.

Principal Investigators and study teams should follow these best practices during the FDA Inspection.

Best practices during an FDA inspection

Step4

After the FDA inspection.

The Principal Investigator (PI) should discuss any FDA Observations during the Exit Meeting to ensure that the issues are fully understood, but should always provide an official response to FDA in writing following the meeting.

What happens after the FDA Inspection?

Guidance, Tools, and Templates