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CLOSEOUT LETTER

Genomyx LLC Apr 04, 2017

Genomyx LLC - Close Out Letter 4/4/17


Genomyx LLC

 

  

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740

APRIL 4, 2017

Dustin Lebleu, CEO
Genomyx LLC
805 Cottonwood Road Annex 3
Harrison, AR 72601

Dear Mr. Lebleu:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 447337, issued April24, 2015. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Latasha A. Robinson
Branch Chief
Dietary Supplement and Labeling
Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

Cc:
Ben Glover
Chief Operations Officer