1020295
Nowcos Co., Ltd — FEI 3009968674
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 4, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sejong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |