FDA 483 - New York Blood Center Enterprises

The FDA inspected New York Blood Center, National Cord Blood Program, and found significant deficiencies in their quality system. Observations included inadequate corrective and preventive action (CAPA) management, failure to follow quality control unit procedures, and lack of documented training for personnel making critical quality decisions. Additionally, the firm failed to properly manage changes to storage and laboratory locations, including not reporting a change to the Agency.