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CLOSEOUT LETTER

Hsu's Ginseng Enterprises, Inc Jun 13, 2017

Hsu's Ginseng Enterprises, Inc - Close Out Letter 6/13/17


Hsu's Ginseng Enterprises, Inc

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Human and Animal Foods, Division 1 West
250 Marquette Avenue, Suite 600
Minneapolis, MN SS401
(612) 334-4100 

June 13, 2017

Paul C. Hsu
President
Hsu's Ginseng Enterprises, Inc.
T6819 County Road W
Wausau, Wisconsin 54403-9461

Dear Mr. Hsu:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Waming Letter MIN 16-14 dated July 22, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this Waming Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainabiiity 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/
CDR Christopher van Twuyver
Director, Compliance Branch
Human and Animal Foods, Division 1 West