FDA 483 - Department of Defense - Army - March 24, 2023

An FDA inspection of D. D. Eisenhower Army Medical Center's Blood Bank in Fort Gordon, GA, revealed two significant observations. The facility failed to ensure sterile phlebotomy site preparation according to its own procedures, and also failed to properly document donor screening test results, impacting the complete history of work performed. These issues indicate deficiencies in critical blood collection and record-keeping practices.