FDA Inspection
Pure Energy Products, Inc.Pure Energy Products, Inc. – FDA Inspection, Jun 24, 2016
Record Details
This FDA Inspection record concerns Pure Energy Products, Inc., with an inspection on June 24, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Pure Energy Products, Inc.
- Inspection Date
- June 24, 2016
- Product Type
- Food/cosmetics
View Company Profile
ID · 4e8ad035-b6de-4244-b4ac-51325635f8da
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 975303
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.475(b)(2)Records - product distribution
- 21 CFR 111.465(b)Retain reserve samples - 1 year, 2 years
- 21 CFR 111.60(a)Production, in- process control system - design, quality
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pure Energy Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| October 19, 2012 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Pure Energy Products, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.