FDA Inspection 1001562 — Novartis Pharmaceuticals Corporation
The FDA completed an inspection of Novartis Pharmaceuticals Corporation on Jan 24, 2017 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 24, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- East Hanover, NJ (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7557 | 21 CFR 312.56(b) | Notification of FDA of termination of investigator |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |