483
U.S. Navy Medicine Readiness and Training Command Naples ItalyU.S. Navy Medicine Readiness and Training Command Naples Italy – FDA 483, Apr 15, 2025
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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ID · a90dfa44-e5d0-4a3c-a06e-66706b959c12
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