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FDA Inspection
•Nutraceutical Evolution, Inc.•August 17, 2012

Nutraceutical Evolution, Inc. – FDA Inspection, Aug 17, 2012

Record Details

This FDA Inspection record concerns Nutraceutical Evolution, Inc., with an inspection on August 17, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Nutraceutical Evolution, Inc.
Inspection Date
August 17, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · fd30c41f-ec0c-489a-aaf2-56059a0bbdaa

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
796211
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

13
  1. 21 CFR 111.80(a)Components packaging, labels received
  2. 21 CFR 111.80(c)Specifications - representative samples; finished batch
  3. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  4. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.103Written procedures - quality control operations
  7. 21 CFR 111.303Written procedures - tests, examinations; specifications met
  8. 21 CFR 111.55Production, process controls - implement
  9. 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
  10. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Nutraceutical Evolution, Inc.

3
DateClassificationOfficeProject area
January 14, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 16, 2009OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 16, 2009NAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
Other documents for Nutraceutical Evolution, Inc.
  • FDA Inspection 813610 - 2013-01-14
  • FDA Inspection 630177 - 2009-11-16
  • FDA Inspection 629621 - 2009-11-16

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