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CLOSEOUT LETTER

Bellisio Foods Inc Aug 17, 2016

Bellisio Foods Inc - Close Out Letter 8/17/16


Bellisio Foods Inc

  

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

 
 Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
         FAX: (513) 679-2761

VIA United Parcel Service

August 17, 2016

Joel Conner, Chairman and Chief Executive Officer
Bellisio Foods, Inc.
525 Lake Avenue South
Suite 201
Duluth, MN 55802-2300

RE: WARNING LETTER CIN-14-421088-14

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CIN-14-421088-14, dated June 12, 2014. 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.

 

/S/

Stephen J. Rabe
Compliance Officer


cc

Michael A. Evans, Senior Vice President
Bellisio Foods Inc
100 E Broadway St
Jackson, OH 45640-1347