483
BloodworksFDA 483 - Bloodworks - December 11, 2025
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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.
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ID · d3659a01-54da-4029-bf72-d2878272359f