FDA 483 - Department of Defense - Army - May 09, 2025

An FDA inspection of D. D. Eisenhower Army Med. Ctr., a Military Blood Bank and Military Donor Center, revealed two significant observations. The facility failed to ensure sterile phlebotomy site preparation, allowing non-sterile items to touch the venipuncture site after disinfection. Additionally, standard operating procedures for donor lookback and recipient notification were not followed, with no Medical Director determination or recipient notification documented for transfused units.