FDA inspection
Novartis Gene Therapies, Inc.: FDA inspection ending Aug 27, 2021
FDA inspection 1155029 · Voluntary Action Indicated (VAI) · San Diego, CA
Key facts
| Inspection ID | 1155029 |
|---|---|
| Firm | Novartis Gene Therapies, Inc. |
| FEI number | 3014617030 |
| Address | 10210 Campus Point Dr Ste 300 |
| City | San Diego |
| State | CA |
| ZIP | 92121 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Aug 27, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
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