FDA 483 - University Medical Center Transfusion Service - July 23, 2019

The FDA inspected the University Medical Center Transfusion Service in Lubbock, TX, from July 22-23, 2019. The inspection identified a significant issue with record-keeping, specifically the failure to maintain concurrent records for the storage and distribution of blood and blood components. This deficiency resulted in the inability to trace the final disposition of specific plasma and platelet units.