FDA Inspection
New Generation Wellness Inc.New Generation Wellness Inc. – FDA Inspection, Oct 27, 2017
Record Details
This FDA Inspection record concerns New Generation Wellness Inc., with an inspection on October 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d9b3f9f9-391d-40e7-9472-e1a4354fb5bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030011
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.58Buildings not maintained in good state of repair
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Other FDA inspections of New Generation Wellness Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2025 | VAI | Denver District Office | Food Composition, Standards, Labeling, and Economics |
| December 13, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 15, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 30, 2012 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for New Generation Wellness Inc.
- FDA Inspection 1278486 - 2025-08-26
- FDA Inspection 1080706 - 2018-12-13
- FDA Inspection 907454 - 2014-12-15
- FDA Inspection 859447 - 2013-12-18
- FDA Inspection 809219 - 2012-11-30
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