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CLOSEOUT LETTER

Vande Hey, Bruce


Vande Hey, Bruce

  

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

May 16, 2016


Bruce P. Vande Hey
Owner
915 Washington Street
Wrightstown, Wisconsin 54180

Dear Mr. Vande Hey:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 16-10 dated April 12, 2016. 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