Ultragenyx Pharmaceutical Inc.April 25, 2025

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

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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.

Company: Ultragenyx Pharmaceutical Inc.
Inspection Date: April 25, 2025
Product Type: Drugs
Office: New England District Office
People: Jacob L. Bitterman
Massoud Motamed (Biologist at CBER)
Kula N. Jha
Timothy Kamaldinov

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ID · 70111f2c-40e7-4d0b-a68c-6fbc4e784cf8