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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Lumen Soy Foods, LLC - Close Out Letter 5/24/12

  

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

Public Health Service
Food and Drug Administration
 

New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217-2565
Telephone: (615) 366-7801
FAX: (615) 366-7802

May 24, 2012

Dana Dykstra, President
Lumen Soy Foods, LLC
16142 Harbor View Drive
Spring Lake, Michigan 49456

Dear Mr. Dykstra:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter No. 2011-NOL-16, dated May 25, 2011. Based on our evaluation, it appears 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/

Ruth P. Dixon
Compliance Branch Director
New Orleans District

 

cc:  David T. Masciarelli, COO
       Lumen Soy Foods, LLC
       838 East Highway # 103
       Lexington, Kentucky 40502

       Kevin Marcantel, Operation Manager
       Lumen Soy Foods, LLC
       409 Scott Street
       Lake Charles, Louisiana 70601