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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Heartland Gourmet, LLC - Close Out Letter 11/8/13

  

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

Public Health Service
 
 Food and Drug Administration
Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340

Telephone: (913) 752-2100

 

November 8, 2013


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mark and Susan Zink, Managers
Heartland Gourmet, LLC
1700 Cushman Dr.
Lincoln, NE 68512-1238


Dear Mr. and Mrs. Zink,

The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter [KAN 2013-8, April 3, 2013]. 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 action should violations be observed during a subsequent inspection or through other means.

 

Sincerely,

/S/

Dr. Ann Adams
Acting District Director
Kansas City District


Cc: Nathan W. Bell, Owner
      2120 Sky View Court
      Moraga, CA 94556