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FDA Inspection
•Mericon Industries Inc.•September 27, 2019

Mericon Industries Inc. – FDA Inspection, Sep 27, 2019

Record Details

This FDA Inspection record concerns Mericon Industries Inc., with an inspection on September 27, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Mericon Industries Inc.
Inspection Date
September 27, 2019
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Liliya V. Bubiy (FDA Associated Person)
View Company Profile

ID · 5a66ad8e-b03b-46f8-a218-c2bfba6fe8f7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1105178
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

10
  1. 21 CFR 111.12Personnel - quality control personnel - qualified
  2. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  3. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  4. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  5. 21 CFR 111.103Written procedures - quality control operations
  6. 21 CFR 111.103Written procedure quality control operations material review
  7. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  8. 21 CFR 111.260(e)Batch record - component; identity, weight
  9. 21 CFR 111.205(b)(2)Master manufacturing record - controls, procedures
  10. 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mericon Industries Inc.

5
DateClassificationOfficeProject area
February 14, 2025OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 21, 2024OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
April 27, 2012NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
May 27, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 11, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Mericon Industries Inc.
  • FDA Inspection 1261237 - 2025-02-14
  • FDA Inspection 1247200 - 2024-08-21
  • FDA Inspection 778091 - 2012-04-27
  • FDA Inspection 727375 - 2011-05-27
  • FDA Inspection 651780 - 2010-03-11

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