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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Karlsburger Foods, Inc. Close out Letter 10/31/11


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) 758-7194MI
FAX: (612) 334-4142 


October 31, 2011

Michael M. Maher
President/Chief Executive Officer
Karlsburger Foods, Inc.
3236 Chelsea Road West
Monticello, Minnesota 55362

Dear Mr. Maher:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 11-08 dated December 16, 2010. 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.

Rebecca L. Caulfield
Compliance Officer
Minneapolis District