# FDA 483 - Bloodworks - May 10, 2019

Source: https://www.keypedia.com/records/483/bloodworks/09bb3206-7bad-484a-8f44-b21aa45f74d8

> FDA 483 for Bloodworks on May 10, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bloodworks
- Inspection Date: 2019-05-10
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Bloodworks in Bellevue, WA, identified a significant lapse in donor management. The firm failed to properly defer an ineligible donor in their electronic system, leading to the collection of apheresis plasma donations from this individual on multiple occasions. This indicates a critical failure in ensuring the suitability of blood and blood components.

## Related Officers

- [Investigator](https://www.keypedia.com/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.keypedia.com/companies/bloodworks/f2ad1a4e-fc84-4177-9ed6-fd42a6088ea6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822