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) identified significant deficiencies in record-keeping practices. Observations included incomplete processing records for red blood cell deglycerolization and inadequate documentation for centrifuge maintenance used in compatibility testing. These issues indicate a failure to maintain detailed records necessary for a complete history of work performed.