University of California Irvine Medical Center Campus Donor Center – FDA 483, May 15, 2024

The University of California Irvine Medical Center Campus Donor Center was cited for three observations during an FDA inspection. The firm failed to obtain complete donor contact information, did not thoroughly investigate discrepancies and documentation error trends, and did not adhere to its own standard operating procedures for collection equipment quality control. These issues indicate deficiencies in donor screening, incident investigation, and procedural compliance.