1195116
Elysium Pharmaceuticals Limited — FEI 3005183272
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 16, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Vadodara (India)
Citations
| ID | CFR | Description |
|---|
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |