American National Red CrossDecember 10, 2025

FDA 483 - American National Red Cross - December 10, 2025

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An FDA inspection of the American National Red Cross donor center in Lehi, UT, identified two significant deficiencies. The firm failed to adequately explain the risks and hazards of the apheresis procedure to donors during the consenting process. Additionally, standard operating procedures lacked a written description and method for controlling the storage temperatures of platelets awaiting transport to manufacturing.

Company: American National Red Cross
Inspection Date: December 10, 2025
Product Type: Biologics
Office: FDA District Office — Denver, Colorado
Person: Emily B. Camire

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ID · 8f32465b-1864-4a1a-8e36-00b545de4fb4