FDA Inspection 678406 — Korea Ginseng Bio-Science Co., Ltd.
The FDA completed an inspection of Korea Ginseng Bio-Science Co., Ltd. on August 20, 2010 in Paju. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 20, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Paju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 3068 | 21 CFR 114.80(a)(1) | pH control |
| 3857 | 21 CFR 113.60(a) | Record: visual closure examination, qualified person |
| 3872 | 21 CFR 113.60(a)(3) | Closures other than double seams and glass |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 4517 | 21 CFR 108.35(c)(2)(ii) | Process change substantiation |
| 4524 | 21 CFR 108.35(g) | Approved school |