FDA Inspection 1012781 — LG Chem., Ltd.
The FDA completed an inspection of LG Chem., Ltd. on Jun 2, 2017 in Iksan. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 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 |