FDA 483 - Department of Defense - Navy - March 04, 2026

An FDA inspection of the Department of Defense - Navy's Hospital Blood Bank in Agana Heights, GU, revealed a significant failure in donor screening procedures. The firm did not consistently obtain confirmation from donors regarding their postal address for 8 weeks post-donation, a critical requirement for donor traceability. This issue was observed during donor screenings and was also noted as a deficiency in the firm's standard operating procedures.