FDA Inspection 1012796 — Mylan Laboratories Limited (FDF-2)
The FDA completed an inspection of Mylan Laboratories Limited (FDF-2) on May 26, 2017 in Chhatrapati Sambhajinagar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 26, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chhatrapati Sambhajinagar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |