FDA Inspection
Ultragenyx Pharmaceutical Inc.Ultragenyx Pharmaceutical Inc. – FDA Inspection, Jun 20, 2017
Record Details
This FDA Inspection record concerns Ultragenyx Pharmaceutical Inc., with an inspection on June 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d5c7d3c8-6d16-43a6-9227-06fd3ae78ce0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015263
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.50Ensuring compliance with plan and protocol
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Other FDA inspections of Ultragenyx Pharmaceutical Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 17, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 27, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ultragenyx Pharmaceutical Inc.
- FDA Inspection 1277227 - 2025-07-17
- FDA Inspection 1199790 - 2023-02-27
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