FDA inspection
Novartis Manufacturing LLC: FDA inspection ending Oct 27, 2023
FDA inspection 1223930 · Voluntary Action Indicated (VAI) · Indianapolis, IN
Key facts
| Inspection ID | 1223930 |
|---|---|
| Firm | Novartis Manufacturing LLC |
| FEI number | 3019881323 |
| Address | 8520 Challenger Drive |
| City | Indianapolis |
| State | IN |
| ZIP | 46241 |
| Fiscal year | 2024 |
| Inspection end date | Oct 27, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | New Drug Evaluation |
| Product type | 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