1012781
LG Chem., Ltd. — FEI 3003031339
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 2, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Iksan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |