FDA 483 - HemaCare Corporation - November 28, 2007

HemaCare Corporation, a blood bank in Van Nuys, CA, was cited for multiple deficiencies related to donor record management, audit trails, and corrective actions during an FDA inspection from July to November 2007. Repeated observations highlighted issues with the Donor Deferral Registry's accuracy and incomplete corrective actions for biological product deviations. The inspection revealed systemic problems in data integrity, donor notification, and adherence to standard operating procedures.