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 the FDA about an upcoming inspection.
Notification ProceduresStep2
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 InspectionStep3
During the FDA inspection
Principal Investigators and study teams should follow these best practices during the FDA Inspection.
Best practices during an FDA inspectionStep4
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 the FDA in writing following the meeting.
What happens after the FDA Inspection?Guidance, Tools, and Templates
- Please contact FDAConsults@ucsf.edu to obtain the latest guidance on preparing for FDA Inspections:
- UCSF FDA Inspection Guidance (December 2024)
- UCSF FDA Inspection Documentation Checklist (December 2024)
- See the UCSF Roles & Responsibilities for FDA Inspections
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FDA Guidance:
- Clinical Inspections of Investigators external site (opens in a new window) (June 2010)
- Compliance Program Guidance Manual for FDA Staff external site (opens in a new window) (Dec 2008)