1064773
ATLAS R&D Inc — FEI 3010515816
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cambridge (Canada)
Citations
| ID | CFR | Description |
|---|
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |