FDA Inspection 1170427 — Mylan Laboratories Limited
The FDA completed an inspection of Mylan Laboratories Limited on May 27, 2022 in Anekal Taluk, Bangalore. 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
- May 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anekal Taluk, Bangalore (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |