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 or email
- Lead time: PI is usually notified less than two weeks before the initiation of the inspection
- PI should try to gather key information during the call or email exchange (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
Step2
Notify key contacts of FDA inspection
The following individuals should be notified:
- Study sponsor (unless the Principal Investigator is also the Sponsor)
- Campus contacts
- Institutional Review Board (IRB) Quality Improvement Unit: ucsfQIU@ucsf.edu external site (opens in a new window)
- Compliance Office / Regulatory Support: FDAConsults@ucsf.edu external site (opens in a new window)
- Office of Legal Affairs, if there are legal concerns