483
U.S. Navy Medicine Readiness and Training Command Naples ItalyFDA 483 - U.S. Navy Medicine Readiness and Training Command Naples Italy - April 15, 2025
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Record Details
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.
- Inspection Date
- April 15, 2025
- Product Type
- Biologics
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