FDA Inspection 1247347 — Geumsan Black Ginseng Co. Ltd.
The FDA completed an inspection of Geumsan Black Ginseng Co. Ltd. on August 22, 2024 in Geumsan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 22, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Geumsan (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22886 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications, quality; packaging, labeling |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3078 | 21 CFR 114.80(b) | Code - required elements |