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

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.