FDA 483 - Hendrick Regional Blood Center - March 07, 2022

An FDA inspection of Hendrick Regional Blood Center in Abilene, TX, revealed multiple significant deficiencies in donor screening and blood collection processes. The firm failed to adequately inspect donors for signs of intravenous drug use, adhere to standard operating procedures for severe donor reactions and deferrals, and ensure proper donor weighing and privacy during screening. These observations indicate a concerning lack of compliance with federal regulations governing blood bank operations.