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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sharkco Seafood International L.L.C. - Close Out Letter 5/1/13

  

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

Telephone: (615) 366-7801
FAX: (615) 366-7802

 

May 1, 2013

 


Tuan Q. Nguyen
Sharkco Seafood International, L.L.C.
707 Jump Basin Road
Highway 23 South
Venice, Louisiana 70091


Dear Mr. Nguyen:

The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2013-NOL-02 dated November 20, 2012. 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. Additionally, you, Mr. Khai Q. Nguyen, and your firm continue to be bound by all the terms of the Consent Decree of Permanent Injunction entered in United States v. Sharkco Seafood International, Inc. et al., Civil No. 2:09-cv-7459 (E.D. La.) on September 22, 2010. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter does 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: K.hai Q. Nguyen
     Sharkco Seafood International, L.L.C.
     707 Jump Basin Road
     Highway 23 South
     Venice, Louisiana 70091

   
     Laurie W. Howenstine
     Baldwin Haspel Burke & Mayer, L.L.C
     1100 Poydras Street, Suite 3600
     New Orleans, Louisiana 70163