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FDA Inspection
•Pure Edge Nutrition LLC.•October 8, 2013

Pure Edge Nutrition LLC. – FDA Inspection, Oct 8, 2013

Record Details

This FDA Inspection record concerns Pure Edge Nutrition LLC., with an inspection on October 8, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Pure Edge Nutrition LLC.
Inspection Date
October 8, 2013
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 0bd5a22f-1d37-40c3-ab15-272bc83cded4

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
851249
FDA center
Human Drugs
Project area
Unapproved and Misbranded Drugs

FDA Citations

3
  1. 21 CFR 111.12Personnel - quality control personnel - qualified
  2. 21 CFR 111.475(a)Records-holding, distribution: originals, copies, electronic
  3. 21 CFR 111.75(c)Specifications met - verify; finished batch

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pure Edge Nutrition LLC.

1
DateClassificationOfficeProject area
April 22, 2014VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Pure Edge Nutrition LLC.
  • FDA Inspection 875390 - 2014-04-22

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