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  5. Pesca Fina, S.A. - 524192 - 04/16/2018
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CLOSEOUT LETTER

Pesca Fina, S.A. MARCS-CMS 524192 —


Recipient:
Pesca Fina, S.A.

United States

Issuing Office:

United States


 

   

Black HHS-Blue FDA Logo

 

 

 
5001 Campus Drive
College Park, MD 20740 

April 16, 2018

Mr. Constantino Rusodimos, General Manager
Pesca Fina, S.A.
Port of Vacamonte
Vista Alegre, Arraijan, Panama

Dear Mr. Rusodimos:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #524192, issued July 18, 2017. Based on our evaluation, it appears you have addressed the violations contained in the 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/

Robyn Jones
Team Leader
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition 

 
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