# FDA 483 - SRI International - August 09, 2024

Source: https://www.globalkeysolutions.net/records/483/sri-international/b486a443-de64-41ea-91a9-6248176cad38

> FDA 483 for SRI International on August 09, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SRI International
- Inspection Date: 2024-08-09
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [other](https://www.globalkeysolutions.net/people/erin-m-mcdowell/7f3995e6-5596-4b3a-a99b-27d49d4b890e)
- [Kristin M. Abaonza](https://www.globalkeysolutions.net/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.globalkeysolutions.net/companies/sri-international/72034a5a-bce6-4e98-a097-0288e4e18fee

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b