FDA Inspection 808205 — Umeken Co. Ltd. (Toyoma Factory #1)
The FDA completed an inspection of Umeken Co. Ltd. (Toyoma Factory #1) on November 15, 2012 in Toyama. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 15, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Toyama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15508 | 21 CFR 111.27(a)(5)(ii) | Refrigerator, freezer - alarm |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15726 | 21 CFR 111.365(f) | Holding - prevent becoming adulterated |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |