FDA Inspection 801129 — Imuraya Co., Ltd. - Tsu Plant
The FDA completed an inspection of Imuraya Co., Ltd. - Tsu Plant on Sep 12, 2012 in Tsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Tsu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1552 | 21 CFR 110.35(a) | Buildings/sanitary |
| 1660 | 21 CFR 113.40(a)(1)(v) | TID not reference instrument |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4524 | 21 CFR 108.35(g) | Approved school |