FDA Inspection Guidance, Tools & Templates

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General Guidance for Site Inspections
PDF of all information contained in this website section

FDA Pre-Inspection Checklist
Organizational tool to aid inspection preparation

FDA Inspection Information
Intake form for FDA/OHRP Inspection Requests

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

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

Cancer Center FDA Inspection Guidance