FDA 483 - UCH-MHS - October 31, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Office
- Denver District Office
- Person
ID · 27ac009e-87e0-4fb3-8539-4275f8ef0dad