FDA Inspection 701017 — SANUKI KANZUME CO., AKITA PLANT
The FDA completed an inspection of SANUKI KANZUME CO., AKITA PLANT on November 19, 2010 in Yurihonjo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Yurihonjo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1648 | 21 CFR 113.40(a)(1) | No TID |
| 1740 | 21 CFR 113.40(a)(2) | Sensor well bleeder size |
| 3864 | 21 CFR 113.60(a)(1) | Recording of teardown examinations |
| 3874 | 21 CFR 113.60(b) | Cooling water - not chlorinated, sanitized |
| 4517 | 21 CFR 108.35(c)(2)(ii) | Process change substantiation |