FDA Inspection 1119549 — KEUM HAN Industrial
The FDA completed an inspection of KEUM HAN Industrial on Feb 18, 2020 in Gangreung-Si. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 18, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Gangreung-Si (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 18142 | 21 CFR 117.35(a) | Sanitary operations - Plant sanitation |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 6008 | 21 CFR 123.8(a)(3) | Verification - record review - frequency |
| 6012 | 21 CFR 123.8(a)(3)(iii) | Calibration record review adequacy |
| 906 | 21 CFR 123.6(b) | HACCP plan location |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |