FDA 483 - The American National Red Cross - June 27, 2023

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.