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  5. Harbor Seafood Inc. - 486585 - 11/16/2017
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CLOSEOUT LETTER

Harbor Seafood Inc. MARCS-CMS 486585 —

Recipient:
Harbor Seafood Inc.

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

Office of Regulatory Affairs
Office of Enforcement and Import Operations
Division of Northeast Imports 
 
 

November 16, 2017

Mr. Peter Cardone, Chairman of the Board
Mr. Christian Limber, President
Harbor Seafood, Inc.
969 Lakeville Road
New Hyde Park, NY 11040-3008

Dear Mr. Cardone and Mr. Limberg:

The Food & Drug Administration received has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-2016-20, dated January 8, 2016. 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/

Slater K. Bartlett
Acting Compliance Officer
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration
 

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