FDA Inspection 715718 — Novartis Pharmaceuticals Corporation
The FDA completed an inspection of Novartis Pharmaceuticals Corporation on Feb 25, 2011 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 25, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- East Hanover, NJ (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7453 | 21 CFR 312.56(b) | Investigator non-compliance |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |