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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Roberts Ranch of Oklahoma LLC - Close Out Letter 9/25/13

  

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

Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

 

September 25, 2013


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Myrl Mortensen, Senior Vice President and Managing Partner
Baxter Gutknecht, Senior Vice President and Managing Partner
The Hanor Company of Wisconsin, LLC
Roberts Ranch of Oklahoma LLC
E4614 Highway 14 & 60
Spring Green, Wisconsin 53588


Dear Messrs. Mortensen and Gutknecht:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions since receiving Warning Letter 2012-DAL-WL-32. 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.


Sincerely,

/S/

Shari J. Shambaugh
Director, Compliance Branch
Dallas District

 

cc Jeff Mencke, Operations Manager
    Roberts Ranch of Oklahoma, LLC
    3025 S. Van Buren
    Enid, Oklahoma 73703