FDA 483 - Charles River Laboratories Cell Solutions Inc - September 03, 2013

Hemacare Corporation, a blood bank and donor center in Van Nuys, CA, received an FDA Form 483 for failing to perform thorough investigations of unexplained discrepancies. This included inadequate investigations into erroneously retested CMV positive donor units, leading to inappropriate labeling and shipping, and a failure to determine the root cause of a quarantined unit being labeled and shipped prematurely. These observations highlight significant concerns regarding the firm's quality control and product release processes.