FDA Inspection 1065030 — Green Pharmaceutical Co., Ltd.
The FDA completed an inspection of Green Pharmaceutical Co., Ltd. on Aug 31, 2018 in Jincheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 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 |