FDA Inspection
El-Gen LLCEl-Gen LLC – FDA Inspection, Dec 17, 2018
Record Details
This FDA Inspection record concerns El-Gen LLC, with an inspection on December 17, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · b77aac55-e0af-435f-b038-82e515862630
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1074665
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 111.415(e)Dietary supplement containers - mix-ups
- 21 CFR 111.70(c)(2)Specifications identity, purity strength, composition
- 21 CFR 111.255(b)Batch record - complete
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Other FDA inspections of El-Gen LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2025 | VAI | New York District Office | Food Composition, Standards, Labeling, and Economics |
| July 15, 2022 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 13, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 28, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 31, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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