American Red Cross Blood Services Virginia Region – FDA 483, Sep 13, 2010

The FDA issued a Form 483 to American National Red Cross, Roanoke, VA, following inspections conducted from August 3-6 and September 9-13, 2010, at its blood bank facility. The observations highlight significant deviations from established operational procedures, crucial for ensuring the safety and quality of blood and blood components. Key issues included a systemic failure to consistently follow written standard operating procedures. Specifically, several donor reaction and injury records lacked mandatory Medical Director reviews, recommendations, signatures, and final quality reviews, indicating deficiencies in donor suitability assessment processes. Furthermore, the inspection revealed inaccuracies and non-compliance in the irradiation and labeling processes for blood components. Documentation of irradiation batch records often failed to reflect actual processing times, such as erroneously noting units returned to controlled storage before labeling was complete or recording discrepancies in irradiation duration. There were also instances where irradiated products awaiting later relabeling by different staff were not properly marked, creating potential for mishandling. Finally, the inspection noted a failure to adhere to equipment functional check procedures. During a mobile setup, staff repeatedly attempted to adjust a non-functional automatic trip scale instead of quarantining it after initial failures, as mandated by procedures. These observations indicate a need for the American National Red Cross to review and reinforce its adherence to internal quality procedures, particularly concerning donor suitability assessments, blood component processing documentation, and equipment management, to ensure compliance with regulatory standards for blood banks.