FDA Inspection 701013 — Shida Kanzume Co Ltd
The FDA completed an inspection of Shida Kanzume Co Ltd on Nov 2, 2010 in Choshi. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 2, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Choshi (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1660 | 21 CFR 113.40(a)(1)(v) | TID not reference instrument |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |