1065030
Green Pharmaceutical Co., Ltd. — FEI 3013338037
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jincheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |