# FDA 483 - Naval Medical Center Portsmouth - September 25, 2025

Source: https://www.keypedia.com/records/483/naval-medical-center-portsmouth/0af82382-5589-44a2-85cf-f40325558747

> FDA 483 for Naval Medical Center Portsmouth on September 25, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Naval Medical Center Portsmouth
- Inspection Date: 2025-09-25
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: Naval Medical Center Portsmouth, a hospital blood bank and transfusion services center in Portsmouth, VA, was inspected by the FDA from September 22-25, 2025. The inspection revealed two significant issues: a failure to maintain adequate processing records for blood component irradiation and a failure to consistently follow written standard operating procedures, particularly regarding the timely resolution and closure of deviation investigations. These observations indicate deficiencies in record-keeping and adherence to established quality system procedures.

## Related Documents

- [483 - 2025-09-25](https://www.keypedia.com/records/483/naval-medical-center-portsmouth/60f03301-525f-412d-8f01-c0c05d013fae)

## Related Officers

- [Kenneth L. Smalls](https://www.keypedia.com/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)

Company: https://www.keypedia.com/companies/naval-medical-center-portsmouth/8ad803e1-f8ed-40fd-b753-6a47b3b0d6c1

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64