483
American National Red CrossAmerican National Red Cross – FDA 483, Dec 10, 2025
Record Details
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.
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