FDA 483 - American National Red Cross (The), Lewis and Clark Region - March 31, 2023

The FDA inspected American National Red Cross (The), Lewis and Clark Region in Salt Lake City, UT, from March 20-31, 2023. The inspection revealed a significant issue with record-keeping practices, specifically concerning the documentation of blood products removed from controlled storage. This lapse resulted in units of Leukocyte Reduced Red Blood Cells exceeding their allowed out-of-storage temperature limits.