FDA 483 - Ultragenyx Pharmaceutical Inc. - April 25, 2025

An FDA inspection of Ultragenyx Pharmaceutical Inc. in Bedford, MA, a drug product manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate data integrity and documentation practices, poor facility maintenance, and ineffective deviation management. The firm also demonstrated insufficient quality oversight and failed to establish proper procedures to prevent microbiological contamination during aseptic processing.