FDA Inspection 680379 — Novartis Pharmaceuticals Corp.
The FDA completed an inspection of Novartis Pharmaceuticals Corp. on Sep 16, 2010 in Suffern, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suffern, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |