CLOSEOUT LETTER
Healthy Healing Enterprises, LLC MARCS-CMS 554500 —
- Product:
- Drugs
Food & Beverages
- Recipient:
-
Recipient NameTodd A. Troha
-
Recipient TitleGeneral 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