FDA 483 - American Red Cross Blood Services Tennessee Valley Region - August 31, 2022

An FDA inspection of American Red Cross Blood Services Tennessee Valley Region in Nashville, TN, revealed a significant issue with record-keeping practices. The firm failed to concurrently maintain records for the collection, processing, storage, and distribution of blood and blood components. This deficiency resulted in multiple units of blood and blood components being unlocatable within the inventory system over an extended period.