# FDA 483 - Bloodworks - May 03, 2024

Source: https://www.keypedia.com/records/483/bloodworks/80a76998-4c87-4acc-b8ac-fc1e05a43565

> FDA 483 for Bloodworks on May 03, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bloodworks
- Inspection Date: 2024-05-03
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Bloodworks in Seattle, WA, identified a significant deficiency in drug product component testing. The firm failed to perform specific identity tests for critical materials used in the manufacture of Cord Blood Units over several years. This indicates a lapse in quality control for essential components.

## Related Documents

- [483 - 2025-12-11](https://www.keypedia.com/records/483/bloodworks/d3659a01-54da-4029-bf72-d2878272359f)

## 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/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822