FDA inspection
ULTRAGENYX: FDA inspection ending Apr 30, 2025
FDA inspection 1269530 · Official Action Indicated (OAI) · Woburn, MA
Key facts
| Inspection ID | 1269530 |
|---|---|
| Firm | ULTRAGENYX |
| FEI number | 3023224237 |
| Address | 150 Presidential Way # 4 |
| City | Woburn |
| State | MA |
| ZIP | 01801-1100 |
| Fiscal year | 2025 |
| Inspection end date | Apr 30, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data