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FDA Inspection
•Custompax, Inc., dba Vitaganic•August 28, 2015

Custompax, Inc., dba Vitaganic – FDA Inspection, Aug 28, 2015

Record Details

This FDA Inspection record concerns Custompax, Inc., dba Vitaganic, with an inspection on August 28, 2015, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Custompax, Inc., dba Vitaganic
Inspection Date
August 28, 2015
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 8e1df034-0c5f-419b-8432-f1c096985ec5

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
941449
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

7
  1. 21 CFR 111.210(h)(5)Corrective action plans
  2. 21 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
  3. 21 CFR 111.530Returned dietary supplement - investigation
  4. 21 CFR 111.75(c)(2)Specifications met - test, examinations; compliance
  5. 21 CFR 111.70(b)(1)Specifications - component identity
  6. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  7. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Custompax, Inc., dba Vitaganic

5
DateClassificationOfficeProject area
May 27, 2016OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 25, 2014OAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
November 6, 2012VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 3, 2011OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 9, 2010VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
Other documents for Custompax, Inc., dba Vitaganic
  • FDA Inspection 972356 - 2016-05-27
  • FDA Inspection 897750 - 2014-09-25
  • FDA Inspection 806464 - 2012-11-06
  • FDA Inspection 748186 - 2011-10-03
  • FDA Inspection 665993 - 2010-06-09

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