FDA Inspection
Hawaiian Organic Noni, LLCHawaiian Organic Noni, LLC – FDA Inspection, Aug 21, 2017
Record Details
This FDA Inspection record concerns Hawaiian Organic Noni, LLC, with an inspection on August 21, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · a8a5bea8-cf66-489b-b628-f648614f0fbc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1022868
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.83(a)Reserve sample - collect, hold
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.25(a)Procedures - calibrating instruments
- 21 CFR 111.25Equipment - procedures
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.60(a)Production, in- process control system - design, quality
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Other FDA inspections of Hawaiian Organic Noni, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 16, 2010 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Hawaiian Organic Noni, LLC
- FDA Inspection 1086014 - 2019-04-11
- FDA Inspection 657967 - 2010-04-16
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