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FDA Inspection
•Omega Nutrition U.S.A Inc•July 21, 2022

Omega Nutrition U.S.A Inc – FDA Inspection, Jul 21, 2022

Record Details

This FDA Inspection record concerns Omega Nutrition U.S.A Inc, with an inspection on July 21, 2022, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Omega Nutrition U.S.A Inc
Inspection Date
July 21, 2022
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 7d4f810f-0d2e-421e-b4d8-1dfcc9338de3

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1175992
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

4
  1. 21 CFR 111.70(b)(1)Specifications - component identity
  2. 21 CFR 111.123(a)(1)Quality control operations - master manufacturing record, modifications
  3. 21 CFR 111.123(b)(4)Quality control supplier product released assurance not provided package
  4. 21 CFR 111.113(a)(1)Quality control production, process control; material review, disposition

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Omega Nutrition U.S.A Inc

6
DateClassificationOfficeProject area
September 27, 2023Not classifiedSeattle District Office
August 29, 2018VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
September 30, 2015NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
August 29, 2011VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
December 7, 2010OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 6 other inspections on the company page
Other documents for Omega Nutrition U.S.A Inc
  • FDA Inspection 1224214 - 2023-09-27
  • FDA Inspection 1070214 - 2018-08-29
  • FDA Inspection 942497 - 2015-09-30
  • FDA Inspection 743858 - 2011-08-29
  • FDA Inspection 694719 - 2010-12-07

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