1089838
Mylan Laboratories Limited — FEI 3007648351
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Anekal Taluk, Bangalore (India)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3549 | 21 CFR 211.46(c) | Air recirculation of dust from production areas |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |