FDA 483 - Primary Children's Hospital - April 17, 2025

Primary Children's Hospital in Salt Lake City, UT, was inspected by the FDA from April 15-17, 2025. The inspection revealed a significant issue regarding the maintenance of records for emergency blood transfusions. Specifically, the hospital failed to obtain physician signatures for emergency-released blood products that were subsequently returned untransfused, indicating a lapse in critical record-keeping practices.