FDA 483 - U.S. Navy Medicine Readiness and Training Command Naples Italy - April 15, 2025

An FDA inspection of the Department of Defense - Navy (U.S. Naval Hospital Naples) blood bank in Gricignano Di Aversa, CE, Italy, identified significant deficiencies in record-keeping. Specifically, processing records for deglycerolization of red blood cells and maintenance records for a centrifuge lacked necessary detail to provide a complete history of work performed. These issues indicate a failure to maintain adequate documentation for critical blood bank operations.