FDA Inspection 562113 — Novartis Pharmaceuticals Corporation
The FDA completed an inspection of Novartis Pharmaceuticals Corporation on Feb 5, 2009 in Vacaville, CA. 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
- Feb 5, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vacaville, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |