FDA 483 - SRI International - August 09, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · b486a443-de64-41ea-91a9-6248176cad38