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 prior to the inspection:
- Study sponsor (unless the Principal Investigator is also the Sponsor)
- Campus contacts
- Institutional Review Board (IRB) Quality Improvement Unit: [email protected]
- Compliance Office / Regulatory Support: [email protected]
- Office of Legal Affairs, if any of the following are true:
- The study/PI [is/was] under investigation/review by IRB (e.g., due to allegations of non-compliance, deviations from protocol, privacy breach, etc.), regardless of whether a finding was/has been made;
- There were significant or serious unexpected adverse events and/or other serious issues (including those that could jeopardize the study and/or result in adverse findings);
- There are numerous or serious Patient(s) and/or Representative(s) complaints related to the Study and/or staff;
- There are serious/concerning issues identified (either by the inspector or UCSF Staff) over the course of the inspection (e.g., likely to result in adverse concerns/observations in the FDA-483); or
- The investigator(s)’ conduct towards the study team and/or staff is concerning and/or hinders our ability to comply with other legal and/or policy requirements.