FDA Inspection 736327 — Otoki Corporation Daepoong Factory
The FDA completed an inspection of Otoki Corporation Daepoong Factory on July 22, 2011 in Umseong-gun. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 22, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Umseong-gun (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1472 | 21 CFR 113.83 | Critical factors not stated |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2887 | 21 CFR 113.40(j) | Processing: conform to other systems |
| 2888 | 21 CFR 113.40(j) | Critical factors - frequency measured, recorded |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |