Healthy Healing Enterprises, LLC

CLOSEOUT LETTER Healthy Healing Enterprises, LLC MARCS-CMS 554500 — August 06, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Food & Beverages Recipient: Recipient Name Todd A. Troha Recipient Title General Manager Healthy Healing Enterprises, LLC 7725 Washington Avenue S. Minneapolis , MN 55439 United States Issuing Office: Center for Food Safety and Applied Nutrition 250 Marquette Avenue Suite 600 Minneapolis , MN 55401 United States (612) 334-4100 Dear Mr. Troha: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated August 15, 2018. Based on our evaluation, it appears that 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/ Boun M. Xiong Compliance Officer, West Division 1 – CB Office of Human and Animal Food Operations Content current as of: 08/07/2019 Regulated Product(s) Drugs Food & Beverages