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CLOSEOUT LETTER

Hoof Health LLC dba Hoof Effects Mar 07, 2016

Hoof Health LLC dba Hoof Effects - Close Out Letter 3/7/16


Hoof Health LLC dba Hoof Effects

  

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

 
 Food and Drug Administration
Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142

March 7, 2016


Jeremy J. Kastner
Owner
Hoof Health LLC dba Hoof Effects
W330 S3794 Honeysuckle Drive
Dousman, Wisconsin 536118-9779

Dear Mr. Kastner:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter MIN 15-13 dated July 9, 2015. 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/

Brian D. Garthwaite, Ph.D.
Compliance Officer
Minneapolis District


BDG/ccl