FDA 483 - Hendrick Regional Laboratory Transfusion Services - March 10, 2022

An FDA inspection of Hendrick Regional Laboratory Transfusion Services in Abilene, TX, revealed a significant failure to report biological product deviations. The facility did not submit required reports within 45 days for multiple instances of erroneously issued or unrecorded blood products, including misidentified units and missing inventory. This indicates a serious lapse in regulatory compliance regarding blood product safety and tracking.