FDA Inspection 1086014 — Hawaiian Organic Noni LLC
The FDA completed an inspection of Hawaiian Organic Noni LLC on April 11, 2019 in Anahola, HI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Anahola, HI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15610 | 21 CFR 111.165(d)(1) | Product received - identify |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |