FDA 483 - Medical Center of the Rockies - July 25, 2025

An FDA inspection of Medical Center of the Rockies, a blood bank in Greeley, CO, revealed a significant issue with the storage and management of expired blood components. Investigators found multiple containers of blood components expired by over a year, indicating a failure in maintaining a safe and orderly storage system. The firm also lacked specific SOPs for disposing of expired, non-recalled supplies and its blood bank software did not prevent the use of expired items.