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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Uttecht, Kenneth - Close Out Letter 10/12/11

  

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

Public Health Service
Food and Drug Administration
 

Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142

October 12, 2011

Kenneth L. Uttecht
Co-owner
Uttecht Dairy Farm
N9127 Bluebird Road
Birnamwood, Wisconsin 54414

Dear Mr. Uttecht:

The Food and Drug Administration has completed an evaluation of your letter dated August 11, 2011, which reported corrective actions in response to our Warning Letter 11-40, dated July 28,2011. Based on our evaluation, it appears that you have addressed the violations cited 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/

Timothy G. Philips
Compliance Officer
Minneapolis District