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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Zeinstra Farms, LLC - Close Out Letter 2/4/14

  

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

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

 

February 4, 2014


Mr. Craig A. Zeinstra
Zeinstra Farms LLC
913 122nd Ave
Shelbyville, Michigan 49344


Dear Mr. Zeinstra,

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 26, 2013. Based on our inspection completed on January 10, 2014, 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/

LCDR Kelli Wilkinson
Compliance Officer
Detroit District