FDA Inspection 981928 — Sandoz GmbH
The FDA completed an inspection of Sandoz GmbH on July 5, 2016 in Langkampfen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 5, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Langkampfen (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |