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

Source: https://www.globalkeysolutions.net/records/483/ultragenyx-pharmaceutical-inc/70111f2c-40e7-4d0b-a68c-6fbc4e784cf8

> FDA 483 for Ultragenyx Pharmaceutical Inc. on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ultragenyx Pharmaceutical Inc.
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: New England District Office
- Summary: 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.

## Related Documents

- [483 - 2025-04-25](https://www.globalkeysolutions.net/records/483/ultragenyx-pharmaceutical-inc/c2b193fe-dff1-4ffe-89db-0b25de3b3a01)

## Related Officers

- [Jacob L. Bitterman](https://www.globalkeysolutions.net/people/jacob-l-bitterman/f1868456-2053-4738-a158-93d921a06258)
- [Biologist at CBER](https://www.globalkeysolutions.net/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)
- [Kula N. Jha](https://www.globalkeysolutions.net/people/kula-n-jha/59961b64-fc92-440d-ae53-0bb03cbc9c78)
- [Timothy Kamaldinov](https://www.globalkeysolutions.net/people/timothy-kamaldinov/30dbc3a4-c383-4c18-9d4b-a3b1e6f50860)

Company: https://www.globalkeysolutions.net/companies/ultragenyx-pharmaceutical-inc/eced36f4-f37f-4271-b0fa-cad0b7de872b

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144