FDA 483 - Intermountain Medical Center - May 12, 2022

An FDA inspection of Intermountain Medical Center's Transfusion Service in Murray, UT, revealed a critical failure to report a product at fault in causing a transfusion reaction. Specifically, the facility did not notify its blood supplier of positive bacterial contamination in a Red Blood Cell unit that resulted in a patient's transfusion transmitted infection, violating their own standard operating procedures.