FDA 483 - UCH-MHS - October 31, 2024

UCH-MHS, a Hospital Blood Bank in Colorado Springs, was inspected by the FDA, revealing deficiencies in their operations. The firm failed to maintain complete records for blood and blood component processing, specifically regarding undocumented fault error codes. Additionally, the inspection found that standard operating procedures for handling unacceptable irradiation runs were not consistently followed, leading to the transfusion of units that should have been discarded.