Related Guidance, Tools & Templates

General Guidance for Site Inspections
Customizable template that outlines the process for an FDA/OHRP inspection, and describes activities that should be done to facilitate the inspection

FDA Site Pre-Inspection Checklist and Coordinator Checklist
Organizational tools to aid inspection preparation

FDA Inspection Information
Intake form for FDA/OHRP Inspection Requests

Preparing for an FDA Inspection Presentation for Coordinators to prepare for and participate in external audits and what comprises inpection readiness