At the completion of the Routine or For Cause Audit, the FDA inspector will issue an evaluation of a site inspection via the Establishment Inspection Report (EIR). The FDA auditor may also issue a Form 483 which includes a list of objectionable conditions/deficiencies found during the audit.
The EIR will have one of three ratings:
• NAI (No Action Indicated)
– No significant deviations from the Regulations/GCP were found
• VAI (Voluntary Action Indicated)
– Deviations from the Regulations/GCP noted which may or may not require a response from the investigator, Sponsor, CRO, etc.
- • OAI (Official Action Indicated)– Most serious of the three ratings
- – Serious deviations from the Regulations/GCP were identified by the inspector
- – Require immediate correction by the site
- – May involve regulatory action by the FDA such as issuance of a Warning Letter, fines, and/or criminal prosecution