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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Elder Grove Dairy - Close Out Letter 10/28/13

  

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

 

October 28, 2013


James G. Rankel
Owner
Elder Grove Dairy
W1110 Colby Factory Road
Colby, Wisconsin 54421


Dear Mr. Rankel:

We received your September 3, 2013, letter in response to Warning Letter MIN 13-22. Your letter has been made a part of the Minneapolis District's permanent file for your firm.

The Food and Drug Administration has completed an evaluation of your corrective actions in response to the Warning Letter. 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.

If you have questions about this letter, please contact me at (612) 758-7132.

 

Sincerely,

/S/

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

BDG/ccl