# FDA 483 - Stanford Blood Center - November 26, 2024

Source: https://www.keypedia.com/records/483/stanford-blood-center/3d98ce42-150d-4892-8aa9-1d84af2d5ac4

> FDA 483 for Stanford Blood Center on November 26, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stanford Blood Center
- Inspection Date: 2024-11-26
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: Stanford Blood Center in Palo Alto, CA, was inspected and cited for significant deficiencies in its quality systems. Observations included failure to verify system changes, non-adherence to deviation investigation procedures, inadequate equipment maintenance and validation protocols, and non-compliance with production control and donor screening documentation. These issues indicate a lack of robust controls over critical blood product manufacturing and donor qualification processes.

## Related Documents

- [483 - 2010-06-16](https://www.keypedia.com/records/483/stanford-blood-center/9018f4b0-531f-4439-b5d6-3d0314a4d6ec)

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/stanford-blood-center/63255433-311c-4503-ad0b-c6820849f4fe

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df