Drug factory · FDA FEI 3012208691
Ultragenyx Pharmaceutical Inc.
60 Leveroni Court, Novato, CA, United States
No problems found at FDA's last inspection, Jul 17, 2025.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2017: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Pariglasgene Brecaparvovec | Tests it | Ultragenyx Pharmaceutical Inc. | 69794-333, 69794-334, 69794-335 +10 |
| Triheptanoin | Tests it | Ultragenyx Pharmaceutical Inc. | 69794-050 |
| Vestronidase Alfa | Tests it | Ultragenyx Pharmaceutical Inc. | 69794-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 27, 2023 | No problems found | Bioresearch Monitoring | — |
| Jun 20, 2017 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 20, 2017 inspection
- Ensuring compliance with plan and protocol 21 CFR 312.50
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND. - General responsibilities of sponsors 21 CFR 312.50
Failure to ensure proper monitoring of the study.
Registered with FDA for: analysis.