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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hulsbosch Dairy Farm - Close Out Letter 7/19/13

  

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

Central Region

 Food and Drug Administration
Detroit District Office
300 River Place, Suite 5900
Detroit, MI 48207-3179
Telephone: 313-393-8100
FAX: 313-393-8139

 

VIA UPS


July 19, 2013


Mr. Dominique Hulsbosch
Hulsbosch Dairy Farm
6678 South County Road 700 W
Greensburg, Indiana 47240


Dear Mr. Hulsbosch,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, 2013-DET-02, dated November 16, 2012. 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 actions should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/

Tina M. Pawlowski, Ph.D.
Compliance Officer
Detroit District Office