FDA 483 - ULTRAGENYX - April 30, 2025

An FDA inspection of Ultragenyx Pharmaceutical Inc. in Woburn, MA, a drug testing establishment, revealed significant deficiencies in quality oversight, documentation practices, and the management of invalid assays and deviations. The firm failed to ensure drug product quality and purity due to inadequate control over documentation, spreadsheets, and anomalous event tracking. Furthermore, investigations into invalid assays and deviations were found to be deficient, often failing to identify root causes and prevent recurrence.