FDA Inspection
El-Gen LLCEl-Gen LLC – FDA Inspection, Jan 31, 2012
Record Details
This FDA Inspection record concerns El-Gen LLC, with an inspection on January 31, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- El-Gen LLC
- Inspection Date
- January 31, 2012
- Product Type
- Food/cosmetics
View Company Profile
ID · 31676077-df49-49c9-85bd-de151f5d5a33
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 765870
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
10- 21 CFR 111.210(h)(3)(ii)(B)Components; add, verify
- 21 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.260(c)Batch record - date, time; maintenance
- 21 CFR 111.260(e)Batch record - component; identity, weight
- 21 CFR 111.210(g)Packaging description, representative label
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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 |
| December 17, 2018 | 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 |
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