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FDA Inspection
•Soma Labs Inc.•October 20, 2017

Soma Labs Inc. – FDA Inspection, Oct 20, 2017

Record Details

This FDA Inspection record concerns Soma Labs Inc., with an inspection on October 20, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Soma Labs Inc.
Inspection Date
October 20, 2017
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
People
  • Jessica M. Monteiro (Company Rep)
  • Nancy M. Espinal (FDA Associated Person)
View Company Profile

ID · 5c5a54f0-a70f-43af-b4ab-51509c1952ca

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1029320
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  2. 21 CFR 111.75(h)Tests, examinations - scientifically valid
  3. 21 CFR 111.365(a)Conditions, controls -protect; microorganisms, contamination
  4. 21 CFR 111.325(a)Laboratory operations: electronic
  5. 21 CFR 111.123(b)(2)Quality control - batch, product specifications
  6. 21 CFR 111.77(a)Specifications not met - reject, quality control

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Soma Labs Inc.

8
DateClassificationOfficeProject area
February 7, 2024NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 15, 2018NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
December 12, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 20, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
January 17, 2013OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 8 other inspections on the company page
Other documents for Soma Labs Inc.
  • FDA Inspection 1230637 - 2024-02-07
  • FDA Inspection 1079940 - 2018-10-15
  • FDA Inspection 906747 - 2014-12-12
  • FDA Inspection 844861 - 2013-08-20
  • FDA Inspection 812623 - 2013-01-17

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
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201 Lackawanna Avenue
Scranton, PA, 18503
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