FDA 483 - University of Texas Medical Branch at Galveston - September 11, 2019

The FDA inspected the University of Texas Medical Branch (UTMB) Blood Center in Galveston, TX, on September 10-11, 2019. The inspection revealed a significant issue with record-keeping for emergency blood transfusions. Specifically, a number of emergency release forms lacked complete documentation justifying the emergency action, indicating a lapse in maintaining adequate records.