FDA Inspection 788702 — Ito En (Hawaii) LLC
The FDA completed an inspection of Ito En (Hawaii) LLC on July 2, 2012 in Honolulu, HI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 2, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Honolulu, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1090 | 21 CFR 110.40(d) | Holding, conveying, mfg systems - design & construction |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 1500 | 21 CFR 113.89 | Evaluation by process authority |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1553 | 21 CFR 110.35(a) | Buildings/good repair |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 2115 | 21 CFR 113.40(b)(8) | Drain valve |
| 2886 | 21 CFR 113.40(i) | Thermal process crit factors-measurement adequate & accurate |
| 3874 | 21 CFR 113.60(b) | Cooling water - not chlorinated, sanitized |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4520 | 21 CFR 108.35(c)(3)(ii) | Process information availability |
| 4528 | 21 CFR 108.35(c)(2)(ii) | Process change recording |