FDA Inspection
WellnessOne Inc.WellnessOne Inc. – FDA Inspection, Aug 2, 2019
Record Details
This FDA Inspection record concerns WellnessOne Inc., with an inspection on August 2, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 3a130940-e1f2-4919-90ce-6e124a661a2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098602
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.73Specifications met - contamination limits
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.255(c)Batch record - follow master
- 21 CFR 111.210(a)Master manufacturing record - dietary ingredients
Full citation text and observation details available on the Dashboard.
Other FDA inspections of WellnessOne Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 13, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 29, 2012 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 9, 2011 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 17, 2010 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for WellnessOne Inc.
- FDA Inspection 1245218 - 2024-08-01
- FDA Inspection 1152149 - 2021-09-13
- FDA Inspection 783546 - 2012-05-29
- FDA Inspection 728748 - 2011-06-09
- FDA Inspection 681405 - 2010-09-17
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