FDA Inspection 953529 — KCE LLC
The FDA completed an inspection of KCE LLC on December 22, 2015 in Pahoa, HI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 22, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Pahoa, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |