FDA Inspection
Hawaiian Organic Noni, LLCHawaiian Organic Noni, LLC – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns Hawaiian Organic Noni, LLC, with an inspection on April 11, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 6e464eaf-1acb-4154-bfd0-3c67d0d2fae8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086014
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.165(d)(1)Product received - identify
- 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
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Other FDA inspections of Hawaiian Organic Noni, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2017 | OAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 16, 2010 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Hawaiian Organic Noni, LLC
- FDA Inspection 1022868 - 2017-08-21
- FDA Inspection 657967 - 2010-04-16
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