FDA Inspection 764997 — Novartis Pharmaceuticals Corp.
The FDA completed an inspection of Novartis Pharmaceuticals Corp. on Jan 31, 2012 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suffern, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |