FDA 483 - SRI International - August 09, 2024

During an inspection of SRI International's Nonclinical Laboratory in Menlo Park, CA, the FDA observed a significant issue regarding the management of archives. Specifically, no single individual was designated as responsible for all raw data, documentation, protocols, final reports, and specimens. This lack of a designated archivist with proper access and tracking responsibilities for critical materials like wet tissues and specimens indicates a potential risk to data integrity and record retention.