1012973
AN Co. Ltd. — FEI 3003092574
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 30, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suwon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1818 | 21 CFR 211.84(c)(2) | Appropriate Opening of Component Containers |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4576 | 21 CFR 211.192 | No written record of investigation |