FDA Inspection
Source-Omega LLCSource-Omega LLC – FDA Inspection, Mar 27, 2018
Record Details
This FDA Inspection record concerns Source-Omega LLC, with an inspection on March 27, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · fa9ac699-4ec3-43ca-a843-9fa2eaaea39b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1046118
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.140(b)(1)Records - quality control operations; responsibilities
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.375(b)Records - manufacturing operations; written procedures
- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
- 21 CFR 111.83(a)Reserve sample - collect, hold
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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 |
| January 19, 2023 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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