1223618
C&T Dream Co., Ltd. — FEI 3012668529
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 10, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cheonan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1818 | 21 CFR 211.84(c)(2) | Appropriate Opening of Component Containers |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |