FDA Inspections: Notification

Overview

When contacted by the FDA about an upcoming inspection, the Principal Investigator should take the following steps. 

Step1

Gather details from the FDA inspector.

  • FDA inspector typically contacts the Principal Investigator (PI) by phone
  • Lead time: PI is usually notified less than one week before the initiation of the inspection
  • PI should try to gather key information during the call (utilize the intake form below):
    • Reason for the visit (for-cause or routine)
    • Scope: one protocol; all studies involving a particular drug/device; or all of the PI's studies
    • Anticipated length: ask about expected arrival date/time, and daily schedule

Use the UCSF Intake Form for PI and FDA Inspector.

Step2

Notify key contacts of FDA inspection.

The following individuals should be notified: