FDA 483 - Amarillo VA Health Care System - April 19, 2022

An FDA inspection of Amarillo VA Health Care System - Blood Bank identified a significant failure to maintain equipment used for storing blood and blood products. The facility did not perform preventive maintenance and calibration according to equipment manuals for both a refrigerator storing red blood cells and an ultra-low temperature freezer for fresh frozen plasma. This indicates a serious lapse in equipment upkeep essential for product integrity.