New Generation Wellness Inc.
FDA Regulatory Profile
New Generation Wellness Inc. has 2 FDA recalls, 9 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- F-0384-2021 · Class III · Mar 8, 2021
- Latest inspection
- Aug 26, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 2 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 9 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| F-0384-2021 | Class III | Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU), 40 tablets in blue PET jar… | Mar 8, 2021 |
| F-0385-2021 | Class III | VEGAN VITAMIN D3, 50 mcg (2,000 IU), 60 VEGAN TABLETS in 100cc amber glass bottles. UPC 7 19985… | Mar 8, 2021 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 26, 2025 | Colorado Springs, CO | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1717927 |
| Dec 13, 2018 | Colorado Springs, CO | Food/Cosmetics | No Action Indicated (NAI) | 1717927 |
| Oct 27, 2017 | Colorado Springs, CO | Drugs | Voluntary Action Indicated (VAI) | 1717927 |
| Dec 15, 2014 | Colorado Springs, CO | Drugs | No Action Indicated (NAI) | 1717927 |
| Dec 18, 2013 | Colorado Springs, CO | Drugs | No Action Indicated (NAI) | 1717927 |
| Nov 30, 2012 | Colorado Springs, CO | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1717927 |
| Nov 2, 2012 | Colorado Springs, CO | Drugs | Voluntary Action Indicated (VAI) | 1717927 |
| Oct 25, 2011 | Colorado Springs, CO | Food/Cosmetics | Voluntary Action Indicated (VAI) | 1717927 |
| May 25, 2010 | Colorado Springs, CO | Food/Cosmetics | Official Action Indicated (OAI) | 1717927 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 1717927 | Colorado Springs, CO | 9 | Aug 26, 2025 |