483
Ultragenyx Pharmaceutical Inc.Ultragenyx Pharmaceutical Inc. – FDA 483, Apr 25, 2025
Record Details
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.
View Company Profile
ID · 70111f2c-40e7-4d0b-a68c-6fbc4e784cf8
Other documents for Ultragenyx Pharmaceutical Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.