FDA Inspection 1248201 — Global Geumsan Ginseng Agriculture Co., Ltd.
The FDA completed an inspection of Global Geumsan Ginseng Agriculture Co., Ltd. on Aug 29, 2024 in Geumsan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Geumsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15673 | 21 CFR 111.315(a) | Criteria for establishing specifications |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 3062 | 21 CFR 114.10 | Personnel |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |