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FDA Inspection
•Primarch Manufacturing, Inc.•August 24, 2012

Primarch Manufacturing, Inc. – FDA Inspection, Aug 24, 2012

Record Details

This FDA Inspection record concerns Primarch Manufacturing, Inc., with an inspection on August 24, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Primarch Manufacturing, Inc.
Inspection Date
August 24, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 8845c45c-5523-4dd5-b572-16837a7541a2

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
796480
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

17
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  2. 21 CFR 111.30(b)Equipment - automated - suitability
  3. 21 CFR 111.70(b)(1)Specifications - component identity
  4. 21 CFR 111.70(d)Specifications - labels, packaging
  5. 21 CFR 111.70(e)Specifications - contamination limits
  6. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  7. 21 CFR 111.103Written procedure quality control operations material review
  8. 21 CFR 111.553Written procedures - product complaint
  9. 21 CFR 111.503Written procedures - returned dietary supplement
  10. 21 CFR 111.430(b)Records - packaging, labeling operations

Showing 10 of 17 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Primarch Manufacturing, Inc.

4
DateClassificationOfficeProject area
June 10, 2021NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
October 18, 2017NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 24, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 19, 2013NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Primarch Manufacturing, Inc.
  • FDA Inspection 1146233 - 2021-06-10
  • FDA Inspection 1031883 - 2017-10-18
  • FDA Inspection 901016 - 2014-10-24
  • FDA Inspection 849107 - 2013-09-19

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