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

Source: https://www.globalkeysolutions.net/records/483/us-navy-medicine-readiness-and-training-command-naples-italy/0b817249-806e-407d-a1f7-0e4ddbff60a1

> FDA 483 for U.S. Navy Medicine Readiness and Training Command Naples Italy on April 15, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: U.S. Navy Medicine Readiness and Training Command Naples Italy
- Inspection Date: 2025-04-15
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Lesley Mae P. Lutao](https://www.globalkeysolutions.net/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.globalkeysolutions.net/companies/us-navy-medicine-readiness-and-training-command-naples-italy/dac6a5df-9ea5-4c9b-97ab-8e8116229d33

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8