BloodworksMay 10, 2019

FDA 483 - Bloodworks - May 10, 2019

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Record Details

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.

Company: Bloodworks
Inspection Date: May 10, 2019
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West VI
Person: Peter S. Kessler (Investigator)

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ID · 09bb3206-7bad-484a-8f44-b21aa45f74d8