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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Big O' Smokehouse Inc. - Close Out Letter 2/13/13


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

 Food and Drug Administration
Detroit District
Central Region
300 River Place, Suite 5900
Detroit, MI 48207

Telephone: 313-393-8100
            FAX: 313-393-8139


February 13, 2013

Keith A. Osterhaven, President/Owner
Big O' Smokehouse Inc.
9740 Cherry Valley Avenue SE
Caledonia, MI 49316

Dear Mr. Osterhaven,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to the Warning Letter we issued to you on April 16, 2012. Based on our evaluation, it appears that you have addressed the violation(s) 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.




CDR Kimberly Martin
Compliance Officer, Detroit District