FDA 483 - Hendrick Regional Laboratory Transfusion Services - July 02, 2025

An FDA inspection of Hendrick Regional Laboratory Transfusion Services in Abilene, TX, from June 30 to July 2, 2025, revealed a significant deficiency. The firm failed to maintain complete reports of adverse reactions, specifically regarding an uncompleted investigation into a patient's transfusion reaction. This indicates a lapse in their quality system for tracking and investigating adverse events related to blood products.