1100101
Novartis Pharmaceuticals Corporation — FEI 3010353512
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 21, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Morris Plains, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |