FDA 483 - Dept. of the Army - Armed Services Blood Bank Ctr. - Europe - August 23, 2023

An FDA inspection of the Dept. of the Army - Armed Services Blood Bank Ctr. - Europe in Landstuhl, Germany, revealed a significant deficiency related to the investigation and follow-up of adverse donor reactions. The facility failed to prepare and maintain written reports of these investigations, including conclusions and follow-up actions. This indicates a serious lapse in donor safety protocols and record-keeping.