# FDA 483 - Ultragenyx Pharmaceutical Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/ultragenyx-pharmaceutical-inc/9a6da5b4-ae5a-41d0-8b0b-bfd9a0b63889

> FDA 483 for Ultragenyx Pharmaceutical Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ultragenyx Pharmaceutical Inc.
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Ultragenyx Pharmaceutical Inc. in Bedford, MA, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate quality oversight leading to errors in Master Batch Records, insufficient acceptance criteria, and manufacturing spaces not adequately cleaned. Additionally, the firm failed to follow written production and process control procedures.

## Related Documents

- [483 - 2025-04-25](https://www.keypedia.com/records/483/ultragenyx-pharmaceutical-inc/70111f2c-40e7-4d0b-a68c-6fbc4e784cf8)
- [483 - 2025-04-25](https://www.keypedia.com/records/483/ultragenyx-pharmaceutical-inc/c2b193fe-dff1-4ffe-89db-0b25de3b3a01)

## Related Officers

- [Miriam M. Ngundi](https://www.keypedia.com/people/miriam-m-ngundi/3999979f-7a00-4d34-8aed-e4426351c99f)
- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Jacob L. Bitterman](https://www.keypedia.com/people/jacob-l-bitterman/f1868456-2053-4738-a158-93d921a06258)
- [Edrinz Siraliev-Perez](https://www.keypedia.com/people/edrinz-siraliev-perez/fd94da0f-97cb-4577-87ef-27eafd5e57c5)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4