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FDA Inspection
•Source-Omega LLC•July 24, 2025

Source-Omega LLC – FDA Inspection, Jul 24, 2025

Record Details

This FDA Inspection record concerns Source-Omega LLC, with an inspection on July 24, 2025, issued by the Cincinnati District Office, covering foods & cosmetics.

Company
Source-Omega LLC
Inspection Date
July 24, 2025
Product Type
Foods & Cosmetics
Office
Cincinnati District Office
People
  • Bailey A. Uetrecht (Company Rep)
  • Shalonda L. Gatewood (Investigator)
  • Siobhan G. Taylor (Issuing Officer)
View Company Profile

ID · 547a6e75-d574-4924-826d-3bd9dc838bd9

Inspection Facts

Inspection number
1276756
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling, and Economics
Outcome
Form 483 issued

FDA Citations

7
  1. 21 CFR 111.16Written procedures - establish; cleaning
  2. 21 CFR 111.205(a)Master manufacturing record - prepared
  3. 21 CFR 111.210Master manufacturing record - record requirements
  4. 21 CFR 111.260Batch record - required information
  5. 21 CFR 111.453Written procedures - establish; holding and distribution
  6. 21 CFR 111.70(e)Specifications - finished dietary supplement
  7. 21 CFR 111.75(c)Specifications met - verify; finished batch

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Source-Omega LLC

3
DateClassificationOfficeProject area
February 28, 2024VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
January 19, 2023OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
March 27, 2018NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Source-Omega LLC
  • FDA Inspection 1232082 - 2024-02-28
  • FDA Inspection 1195118 - 2023-01-19
  • FDA Inspection 1046118 - 2018-03-27

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