483
The American National Red CrossFDA 483 - The American National Red Cross - June 27, 2023
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Record Details
An FDA inspection of The American National Red Cross donor center in Merrillville, IN, revealed a significant quality system deficiency. The firm failed to consistently follow its written standard operating procedures for the storage of blood and blood components. This included a failure to document numerous out-of-range temperature readings and to take immediate corrective actions for these temperature excursions over an extended period.
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ID · 31a8199b-56eb-486c-b608-f214709d7518