1017773
Aztex Enterprises Ltd. — FEI 3003516782
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 13, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burlington (Canada)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |