FDA Inspection
Ekos America, Inc.Ekos America, Inc. – FDA Inspection, Dec 5, 2025
Record Details
This FDA Inspection record concerns Ekos America, Inc., with an inspection on December 5, 2025, issued by the New York District Office, covering foods & cosmetics.
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ID · bd2cb24b-bd0a-4633-a43a-0185d0eb4fc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1294032
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.505(c)(2)Reevaluate - 3 years
- 21 CFR 1.504(a)Hazard analysis written
- 21 CFR 1.506(b)Supplier verification - establish written procedures
- 21 CFR 1.506(e)(1)Verification activity before import, periodically
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Other FDA inspections of Ekos America, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2024 | VAI | New York District Office | Foodborne Biological Hazards |
| November 22, 2023 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 14, 2022 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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