FDA Inspection 643624 — Novartis Pharmaceuticals Corp.
The FDA completed an inspection of Novartis Pharmaceuticals Corp. on Feb 9, 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 9, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suffern, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 8910 | 21 CFR 314.81(b)(2)(iii) | Labeling information |