483
PlasmaLab International, Inc.FDA 483 - PlasmaLab International, Inc. - August 15, 2019
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An FDA inspection of PlasmaLab International, Inc. in Everett, WA, revealed a significant lapse in their quality system regarding donor adverse reactions. The firm failed to prepare and maintain written reports of investigations into adverse reactions, specifically regarding hematomas experienced by multiple donors. This indicates a deficiency in their donor reaction management procedures.
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ID · 2ad89af0-693e-4bb0-a852-9a7f742f754b