FDA Inspection 1086018 — Sandoz Private Limited
The FDA completed an inspection of Sandoz Private Limited on April 12, 2019 in Navi Mumbai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Navi Mumbai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |