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CLOSEOUT LETTER

Harmless Harvest Thailand Apr 06, 2016

Harmless Harvest Thailand - Close Out Letter 4/6/16


Harmless Harvest Thailand

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
College Park, MD 20740

Mr. Guy Gavelle
Managing Director
Harmless Harvest Thailand
7 Moo 5
Kamphaeng-Saen, Nakhon Pathom
73140, Thailand


Dear Mr. Gavelle:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #460982, issued November 13, 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/

Asha S. Dwarka
Compliance Officer
Office of Compliance
Center for Food Safety
     and Applied Nutrition


cc: Doug Riboud, Co-Founder, Harmless Harvest, Inc.
     714 Sansome Street, San Francisco, CA 94111

     Justin Guilbert Co-Founder, Harmless Harvest, Inc.
     714 Sansome Street, San Francisco, CA 94111