483
BloodworksFDA 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.
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ID · 09bb3206-7bad-484a-8f44-b21aa45f74d8