FDA Inspection 1021099 — KGC Life&Gin Co., Ltd.
The FDA completed an inspection of KGC Life&Gin Co., Ltd. on August 11, 2017 in Gwanag-gu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gwanag-gu (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 |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |