Windmill Health Products, LLC FDA Record
Windmill Health Products, LLC has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Windmill Health Products, LLC, the most recent on Oct 7, 2014.
- Latest inspection
- Apr 29, 2025 · NAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Windmill Health Products, LLC FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Oct 7, 2014 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 29, 2025 | West Caldwell, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3008515879 |
| Jun 5, 2024 | West Caldwell, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3008515879 |
| May 28, 2024 | West Caldwell, NJ | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3008515879 |
| Dec 19, 2018 | West Caldwell, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3008515879 |
| Oct 13, 2015 | West Caldwell, NJ | Food/Cosmetics | No Action Indicated (NAI) | 3008515879 |
| Jul 17, 2013 | West Caldwell, NJ | Food/Cosmetics | Official Action Indicated (OAI) | 3008515879 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Windmill Health Products, LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3008515879 | West Caldwell, NJ | 6 | Apr 29, 2025 |
Windmill Health Products, LLC and the FDA: common questions
Has Windmill Health Products, LLC received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Windmill Health Products, LLC. The most recent is dated Oct 7, 2014.
Has Windmill Health Products, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Windmill Health Products, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Windmill Health Products, LLC?
The most recent FDA inspection on file ended Apr 29, 2025 at West Caldwell, NJ and was classified NAI. FDA has 6 inspections of Windmill Health Products, LLC on file, 1 of them classified OAI (official action indicated).
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