FDA Inspection 748066 — Novartis Pharma Produktions GmbH
The FDA completed an inspection of Novartis Pharma Produktions GmbH on September 15, 2011 in Wehr. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wehr (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |