El-Gen LLC FDA Record
El-Gen LLC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to El-Gen LLC, the most recent on Aug 3, 2012.
- Latest inspection
- Apr 2, 2025 · VAI
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 | 7 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 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 |
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El-Gen LLC FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 3, 2012 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 2, 2025 | Bohemia, NY | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3006432830 |
| Jul 15, 2022 | Bohemia, NY | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3006432830 |
| Dec 17, 2018 | Bohemia, NY | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3006432830 |
| Jan 13, 2016 | Bohemia, NY | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3006432830 |
| Feb 28, 2013 | Bohemia, NY | Food/Cosmetics | Voluntary Action Indicated (VAI) | 3006432830 |
| Jan 31, 2012 | Bohemia, NY | Food/Cosmetics | No Action Indicated (NAI) | 3006432830 |
| Jan 31, 2012 | Bohemia, NY | Food/Cosmetics | Official Action Indicated (OAI) | 3006432830 |
- 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 El-Gen LLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3006432830 | Bohemia, NY | 7 | Apr 2, 2025 |
El-Gen LLC and the FDA: common questions
Has El-Gen LLC received an FDA warning letter?
Yes. FDA has issued 1 warning letter to El-Gen LLC. The most recent is dated Aug 3, 2012.
Has El-Gen LLC received an FDA Form 483?
FDA has not published a Form 483 for "El-Gen LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect El-Gen LLC?
The most recent FDA inspection on file ended Apr 2, 2025 at Bohemia, NY and was classified VAI. FDA has 7 inspections of El-Gen LLC on file, 1 of them classified OAI (official action indicated).
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