483
American Red CrossFDA 483 - American Red Cross - September 07, 2023
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The FDA issued a Form 483 to American Red Cross in Virginia Beach, VA, following an inspection from September 5-7, 2023. The inspection revealed a significant issue related to the improper storage of platelet units, specifically regarding temperature control and agitation immediately after collection and resuspension. This indicates a critical lapse in maintaining product quality and safety standards.
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