# FDA 483 - Bloodworks - December 11, 2025

Source: https://www.keypedia.com/records/483/bloodworks/d3659a01-54da-4029-bf72-d2878272359f

> FDA 483 for Bloodworks on December 11, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bloodworks
- Inspection Date: 2025-12-11
- Product Type: biologics
- Office Name: Seattle District Office
- Summary: During an inspection from December 2-11, 2025, the FDA issued a Form 483 to Bloodworks in Seattle, WA, citing a significant lapse in their aseptic processing qualification program. The firm failed to perform required semi-annual media fills for cord blood manufacturing, directly violating their own written production and process control procedures. This indicates a critical deficiency in ensuring the sterility and quality of their products.

## Related Documents

- [483 - 2024-05-03](https://www.keypedia.com/records/483/bloodworks/80a76998-4c87-4acc-b8ac-fc1e05a43565)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/sunitha-k-rajaram/1a0872d4-5e7b-4690-a2be-3877aec25053)
- [investigator](https://www.keypedia.com/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)

Company: https://www.keypedia.com/companies/bloodworks/7ecb0a9c-b4a3-41bb-8c61-3be1042e3e8e

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913