Official Action Indicated (OAI) is an FDA inspection classification indicating significant regulatory violations requiring corrective action.
An OAI finding may result in warning letters, enforcement actions, or follow-up inspections. In clinical research, OAI classifications often relate to informed consent deficiencies, protocol noncompliance, or inadequate recordkeeping. Organizations must implement documented corrective and preventive actions (CAPA) to remediate issues. Effective response and remediation are critical to restoring regulatory confidence and maintaining study continuity.