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  5. Food for Health International, L.L.C. - 01/13/2014
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CLOSEOUT LETTER

Food for Health International, L.L.C.


Recipient:
Food for Health International, L.L.C.

United States

Issuing Office:

United States


  

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

Southwest Region
 Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX:              303-236-3551

 

January 13, 2014


VIA UPS


Frank L. Davis
Chief Operating Officer
Food for Health International, L.L.C.
3560 Ninigret Drive
Salt Lake City, Utah 84104


Dear Mr. Davis:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #DEN-13-1-WL issued on October 5, 2012. Based on our follow-up inspection conducted July 16-25, 2013 and our review of your subsequent FDA-483 Response, it appears that you have addressed the violation(s) 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/

LaTonya M. Mitchell
Denver District Director


LMM/trb