FDA 483 - Versiti Michigan Inc - September 26, 2024

An FDA inspection of Versiti Michigan Inc. in Saginaw, MI, revealed critical deficiencies in record-keeping for blood and blood components. The firm failed to consistently document alarms from apheresis runs and temperature monitoring for storage units, impacting the traceability of collected products. These issues highlight a moderate severity in data integrity and compliance with regulatory requirements for blood banks.