FDA 483 - University of California Irvine Medical Center Campus Donor Center - May 15, 2025

During an inspection conducted from May 13-15, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to the University of California Irvine Medical Center Campus Donor Center. The inspection revealed several significant observations indicating deviations from regulatory requirements for blood and blood component collection, under the Federal Food, Drug, and Cosmetic Act. Key observations included a failure to adequately obtain donor contact information. Specifically, the center did not confirm if donors would remain at their provided address for eight weeks post-donation, a critical aspect for donor follow-up. Furthermore, the facility failed to conduct thorough investigations and document conclusions for significant discrepancies. This included an incident where a blood unit was incorrectly associated with a different donor due to identical names, leading to a blood type mismatch and unit discard. A pervasive trend of documentation errors across donor screening, labeling, and collection processes, such as missing identification numbers and critical checkboxes, also went uninvestigated and uncorrected. Finally, the inspection noted a failure to adhere to established internal operating procedures. A collection mixer repeatedly failed quality control checks but was not removed from service, nor was a supervisor notified, directly contravening the center’s own equipment protocols. The company is expected to address these observations by submitting a response outlining corrective actions to ensure compliance with federal regulations.