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

An FDA inspection of D. D. Eisenhower Army Med. Ctr. in Fort Eisenhower, GA, a military blood bank and donor center, revealed two significant observations. The inspection found issues with phlebotomy site preparation, specifically regarding maintaining sterility during whole blood collection. Additionally, the firm failed to consistently follow standard operating procedures for donor lookback and deferral, leading to a lack of Medical Director determination and recipient notification for transfused units in lookback cases.