FDA Inspection 1280182 — KOKUYO CO.,LTD.
The FDA completed an inspection of KOKUYO CO.,LTD. on September 1, 2025 in Izumo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 1, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Izumo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 16441 | 21 CFR 113.40(f)(2)(ii) | Hydrostatic retorts: digital records, appropriate intervals |
| 2526 | 21 CFR 113.40(f)(1) | No accurate TID |
| 4514 | 21 CFR 108.35(c)(1) | Registration |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4523 | 21 CFR 108.35(f) | Recall procedures |
| 4524 | 21 CFR 108.35(g) | Approved school |