FDA Inspection 1015263 — Ultragenyx Pharmaceutical Inc.
The FDA completed an inspection of Ultragenyx Pharmaceutical Inc. on June 20, 2017 in Novato, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Novato, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |