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FDA Inspection
•PurQuality, LLC•January 23, 2013

PurQuality, LLC – FDA Inspection, Jan 23, 2013

Record Details

This FDA Inspection record concerns PurQuality, LLC, with an inspection on January 23, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
PurQuality, LLC
Inspection Date
January 23, 2013
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · c0fa938b-4a26-4e47-8277-ce66312f872c

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
815713
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

7
  1. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  2. 21 CFR 111.315(d)Standard reference materials; criteria for selecting
  3. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  4. 21 CFR 111.205(c)Master manufacturing record: readily available
  5. 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
  6. 21 CFR 111.75(c)Specifications met - verify; finished batch
  7. 21 CFR 111.110(c)Quality control operations - tests, examinations; results

Full citation text and observation details available on the Dashboard.

Other FDA inspections of PurQuality, LLC

2
DateClassificationOfficeProject area
January 30, 2012OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 27, 2010OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for PurQuality, LLC
  • FDA Inspection 767315 - 2012-01-30
  • FDA Inspection 682548 - 2010-09-27

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Contact
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