1016297
Coway Co., Ltd. — FEI 3012231456
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 19, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gongju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |