Preparing for an FDA or Sponsor Inspection

Preparing for an FDA or Sponsor Inspection

Upon notification of an FDA inspection, please contact the Office of Regulatory Affairs immediately for guidance and assistance.  The ORA provides one-on-one inspection/audit preparation guidance, education on how to interact with the FDA, and provides support for responding to the FDA’s findings, if needed.

If there is a concern about the study preparedness for a Sponsor audit, contact the Office of Regulatory Affairs to request an audit readiness assessment for both industry and investigator-initiated studies. This program helps ensure compliance with FDA, GCP, and IRB regulations, and UCLA Health System policies and guidance, as related to clinical research. The results of the pre-audit assessment will be provided for investigators and teams.

Visit FDA Inspections & Alerts to learn more.