FDA inspection
BioMarin Pharmaceutical, Inc.: FDA inspection ending Dec 9, 2022
FDA inspection 1199333 · Voluntary Action Indicated (VAI) · Novato, CA
Key facts
| Inspection ID | 1199333 |
|---|---|
| Firm | BioMarin Pharmaceutical, Inc. |
| FEI number | 3004079983 |
| Address | 46 Galli Dr |
| City | Novato |
| State | CA |
| ZIP | 94949-5706 |
| Fiscal year | 2023 |
| Inspection end date | Dec 9, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| 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
- Yes Establishment inspection report (EIR) exists
- 10–99 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