FDA Inspection 892403 — Novartis Pharmaceuticals Corporation
The FDA completed an inspection of Novartis Pharmaceuticals Corporation on Aug 5, 2014 in East Hanover, NJ. 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
- Aug 5, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- East Hanover, NJ (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7452 | 21 CFR 312.56(c) | IND safety report |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7483 | 21 CFR 312.55(b) | New observations, adverse effects and risks |