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

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.