FDA Inspection 986244 — Mylan Laboratories Limited
The FDA completed an inspection of Mylan Laboratories Limited on Sep 14, 2016 in Nashik. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 14, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nashik (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 15918 | 21 CFR 111.95(a) | Records - production, process control: electronic |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |