FDA inspection
Novartis Gene Therapies, Inc.: FDA inspection ending Jun 16, 2021
FDA inspection 1144535 · Voluntary Action Indicated (VAI) · Libertyville, IL
Key facts
| Inspection ID | 1144535 |
|---|---|
| Firm | Novartis Gene Therapies, Inc. |
| FEI number | 3012983541 |
| Address | 1940 Usg Dr |
| City | Libertyville |
| State | IL |
| ZIP | 60048 |
| Country | United States |
| Fiscal year | 2021 |
| Inspection end date | Jun 16, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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