FDA 483 - Department of Defense - Navy - June 03, 2025

The FDA issued a Form 483 to the Department of Defense - Navy, a Military Hospital Blood Bank and Transfusion Services in Fort Belvoir, VA, following an inspection. The inspection revealed significant issues primarily related to equipment maintenance and record-keeping for blood and blood components. Deficiencies included inadequate dose mapping of blood irradiators, unperformed or undocumented annual qualification of blood transport coolers, and missing physician signatures on emergency transfusion records. Additionally, standard operating procedures for blood processing, storage, and distribution were found to be incomplete or contradictory.