FDA 483 - UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay - October 17, 2022

An FDA inspection of UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay in San Francisco revealed two significant observations. The facility failed to use supplies and reagents according to manufacturer instructions for antibody identification testing, a practice ongoing since 2014. Additionally, records for compatibility testing of blood and blood components were not concurrently maintained, making it difficult to trace all steps.