FDA Inspection
Source-Omega LLCSource-Omega LLC – FDA Inspection, Jan 19, 2023
Record Details
This FDA Inspection record concerns Source-Omega LLC, with an inspection on January 19, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Person
- James G. Marsh
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ID · d03468a7-1647-420f-919e-f40202b48aaa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1195118
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.105(g)Quality control - reserve samples
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.105(g)Quality control - reserve samples
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
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Other FDA inspections of Source-Omega LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2025 | Not classified | Cincinnati District Office | Food Composition, Standards, Labeling, and Economics |
| February 28, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 27, 2018 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
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