New Dawn Nutrition, Inc.
FDA Regulatory Profile
New Dawn Nutrition, Inc. has 1 FDA recall, 8 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- F-0886-2021 · Class II · Jul 16, 2021
- Latest inspection
- May 3, 2024 · 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 | 1 | 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 | 8 | 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-0886-2021 | Class II | Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle… | Jul 16, 2021 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| May 3, 2024 | Omaha, NE | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3011273154 |
| Aug 6, 2021 | Omaha, NE | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3011273154 |
| Nov 1, 2019 | Omaha, NE | Food/Cosmetics | Official Action Indicated (OAI) | 3011273154 |
| Jan 11, 2017 | Omaha, NE | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3011273154 |
| Jan 11, 2017 | Omaha, NE | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3011200479 |
| Jan 14, 2016 | Omaha, NE | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3011200479 |
| Dec 30, 2014 | Omaha, NE | Food/Cosmetics | No Action Indicated (NAI) | 3011200479 |
| Dec 30, 2014 | Omaha, NE | Food/Cosmetics | Official Action Indicated (OAI) | 3011273154 |
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.