FDA Inspection 1009385 — Novartis Pharmaceuticals A. G.
The FDA completed an inspection of Novartis Pharmaceuticals A. G. on Mar 23, 2017 in Broomfield, CO. 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
- Mar 23, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Broomfield, CO (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 10019 | 21 CFR 314.80(c)(1)(iii) | Non-applicant reports directly to FDA |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |