FDA 483 - The American National Red Cross - July 02, 2008

During an inspection from May 27, 2008, to July 2, 2008, the FDA identified significant compliance issues at the American Red Cross Southeastern Michigan Region, a blood bank facility in Detroit, MI. This FDA Form 483 details observations highlighting deficiencies in their quality management systems, particularly regarding the timely resolution of problems and adherence to established procedures for blood product safety and personnel training. Key observations include persistent delays in the development, review, and approval of Corrective Action Plans (CAPs), with some remaining open for extended periods due to rejections and slow Quality Assurance processing. Furthermore, the firm failed to perform effectiveness checks (ECs) for corrective actions within stipulated timeframes, leaving many issues unassessed for hundreds of days. Decisions by the Material Review Board (MRB) were also significantly delayed, exceeding their 10-day target for initial problem assessment. Product quality control was compromised by inconsistent management of positive bottle alarms in bacterial detection systems for platelet pools, leading to delays in appropriate product disposition and notifications. Non-adherence to established sampling guidelines for quality control monitoring of various blood products was also noted. Critical deficiencies in personnel training documentation were observed, including instances where employees lacked written proof of required training for specific tasks before transfer, and authorized training curricula were not consistently signed and completed by both staff and supervisors. The facility is required to promptly address these observations with comprehensive corrective and preventive actions to ensure compliance with regulatory standards for blood establishments.