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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Herdering, Steven - Close Out Letter 4/19/13

  

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) 758-7132
FAX: (612) 334-4142

April 19, 2013


Steven A. Herdering
Pam Herdering
Owners
North Oak Dairy
29846 County Road 157
Freeport, Minnesota 56331


Dear Mr. and Mrs. Herdering:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 13-11 dated January 23, 2013. 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