FDA 483 - American National Red Cross, Penn Jersey Region - July 29, 2008

The Food and Drug Administration (FDA) conducted an inspection of the American National Red Cross, Penn Jersey Region, a regional blood bank, from July 21 to July 29, 2008. The inspection resulted in the issuance of an FDA Form 483, detailing two significant observations concerning the firm's adherence to regulatory requirements for blood and blood components. The primary issue identified was a failure to thoroughly investigate unexplained discrepancies and maintain complete records of conclusions and follow-up actions. Specifically, problems were not consistently investigated, and corrective action plans (CAPs) were not developed or finalized in a timely manner. The firm's automated problem management system lacked documentation of subsequent actions for multiple identified issues, indicating a systemic delay in addressing quality events. A second observation noted that written standard operating procedures (SOPs) for the collection and processing of blood and blood components were not consistently followed. This was particularly evident in the delayed documentation of necessary activities and actions within the system, with some records showing significant lags between activity occurrence and their entry. These observations highlight deficiencies in the facility's quality management system, particularly regarding timely problem resolution and procedural adherence. The American National Red Cross is required to respond to the FDA 483 with a comprehensive plan outlining corrective actions to address each observation and prevent recurrence.