American National Red Cross (The)July 31, 2025

FDA 483 - American National Red Cross (The) - July 31, 2025

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The American National Red Cross in Modesto, CA, underwent an FDA inspection of its blood donor center. The inspection revealed a critical failure in the storage of platelets, specifically the absence of equipment for continuous gentle agitation, resulting in platelet units being stored improperly for extended durations. This indicates a lapse in maintaining required storage conditions for blood components.

Company: American National Red Cross (The)
Inspection Date: July 31, 2025
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West V
Person: Deepa E. Vadakkan (FDA_PERSONNEL)

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ID · d3ca4ba9-26b6-4ede-bb02-920081669a35