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

Source: https://www.keypedia.com/records/483/naval-medical-center-portsmouth/60f03301-525f-412d-8f01-c0c05d013fae

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

---

## Details

- Record Type: 483
- Company Name: Naval Medical Center Portsmouth
- Inspection Date: 2025-09-25
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Naval Medical Center Portsmouth's Hospital Blood Bank/Transfusion Services/Blood Donor Center identified two observations. The facility failed to maintain adequate processing records for blood component irradiation, specifically regarding the documentation of critical dose and exposure parameters. Additionally, the firm did not consistently follow its standard operating procedures by failing to ensure timely resolution and closure of deviations and investigations.

## Related Documents

- [483 - 2025-09-25](https://www.keypedia.com/records/483/naval-medical-center-portsmouth/0af82382-5589-44a2-85cf-f40325558747)

## 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/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa