FDA 483 - Charles River Laboratories Cell Solutions Inc - September 10, 2009

HemaCare Corporation in Van Nuys, CA, was cited for significant deficiencies in its electronic equipment checking, record-keeping, and standard operating procedures related to donor management. The inspection revealed issues with the computer system's ability to prevent and identify duplicate donor records, a lack of documentation for critical override decisions, and incomplete procedures for resolving potential duplicate donors and communicating deferrals. These findings indicate a moderate level of severity concerning data integrity and procedural control in donor screening.