FDA Inspection
Pure Energy Products, Inc.Pure Energy Products, Inc. – FDA Inspection, Sep 26, 2014
Record Details
This FDA Inspection record concerns Pure Energy Products, Inc., with an inspection on September 26, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Pure Energy Products, Inc.
- Inspection Date
- September 26, 2014
- Product Type
- Drugs
View Company Profile
ID · 3c99c7cf-18a2-475f-8868-6d55be29def4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 896771
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
9- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.475(b)(2)Records - product distribution
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.105(b)Quality control - supplier qualification
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Other FDA inspections of Pure Energy Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2016 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 19, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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