FDA 483 - Charles River Laboratories Cell Solutions Inc - September 08, 2011

Hemacare Corporation, a blood bank in Van Nuys, CA, was cited for significant deficiencies during an FDA inspection. Observations included failures to thoroughly investigate product failures, leading to the distribution of quarantined blood components and inappropriate resolution of duplicate donor records. Additionally, the firm's standard operating procedures lacked adequate descriptions for donor notification and follow-up processes.