CLOSEOUT LETTER

Premier Organics Inc. November 07, 2014

Recipient:: Premier Organics Inc.; United States

Issuing Office:: United States


Department of Health and Human Services	Public Health Service Food and Drug Administration
	College Park, MD 20740

NOV 7, 2014

Santiago Cuenca-Romero, President
Premier Organics Inc.
810 81st Avenue
Suite B
Oakland, CA 94621

Re: 431656

Dear Mr. Cuenca-Romero:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter issued August 12, 2014. Based on our evaluation, it appears that you have addressed the violations contained in this 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
Labeling and Dietary Supplement
Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition

Department of Health and Human Services