NAI – No Action Indicated
Site is in compliance. No actions or response from site necessary
VAI – Voluntary Action Indicated
Violative practices noted that do not immediately jeopardize subject safety, but require correction action. Response necessary; follow-up inspection possible
OAI – Official Action Indicated
Violations severe enough to warrant immediate administrative actions. Reinspection likely
Other Inspections
Routine GMP audits
Directed audit for a specific reason
Reinspection after a Warning Letter
Recall effectiveness check
Preapproval inspection
Special Enforcement Initiative
Top Reasons for FDA inspection
- Routine Inspections, Routine Surveillance, For Cause inspections
- Pre-approval and Post-approval
- Controlling product approvals for commercialization
- Surveillance Programs through Adverse event reports
- Undercover Surveillance (drug/device promotion, distribution)
- Consumer complaints/former employee complaints (Whistle-blower)
- Bioresearch Monitoring Foreign
- Benchmarking, Complaints and Recall related
- New Product/Process Being Implemented