1022742
Codel International Co., Ltd. — FEI 3012269530
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 25, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gangnam (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |