FDA inspection
Novartis Gene Therapies Inc.: FDA inspection ending Dec 10, 2021
FDA inspection 1165325 · No Action Indicated (NAI) · Durham, NC
Key facts
| Inspection ID | 1165325 |
|---|---|
| Firm | Novartis Gene Therapies Inc. |
| FEI number | 3015404862 |
| Address | 2512 S Tricenter Blvd |
| City | Durham |
| State | NC |
| ZIP | 27713-1852 |
| Fiscal year | 2022 |
| Inspection end date | Dec 10, 2021 |
| Classification | No Action Indicated (NAI) |
| Project area | Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood & Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products|Blood and Blood Products |
| Product type | Biologics |
At a glance
- None Citations
- None 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