FDA 483 - Department of Defense - Navy - September 08, 2023

An FDA inspection of Naval Medical Center Camp Lejeune's Hospital Blood Bank and Transfusion facility identified issues with record-keeping practices. Specifically, employees were observed not concurrently documenting donor vital signs and other screening information directly into the computer system during blood collection, leading to concerns about data traceability. This indicates a lapse in maintaining accurate and timely records for significant steps in blood and blood component collection.