FDA 483 - UCSF Health - Pediatric Cellular Therapy Laboratory - March 21, 2023

An FDA inspection of UCSF Health - Pediatric Cellular Therapy Laboratory in San Francisco, CA, revealed two significant observations. The firm failed to verify the performance of computer software used for managing umbilical cord blood products, and its records were found to be inaccurate with numerous discrepancies between daily QC activities and computer audit trails. These issues indicate deficiencies in data integrity and quality system controls.