FDA Inspection 1073408 — Novartis Pharma Stein AG
The FDA completed an inspection of Novartis Pharma Stein AG on Dec 4, 2018 in Stein Ag. 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: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 4, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Stein Ag (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |