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  5. Fresh Directions Dominicana S.A. - 06/22/2017
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CLOSEOUT LETTER

Fresh Directions Dominicana S.A.

Recipient:
Fresh Directions Dominicana S.A.

United States

Issuing Office:

United States

 

  

Black HHS-Blue FDA Logo

 

 

 

5001 Campus Drive
College Park, MD 20740

June 22, 2017

Mr. Manuel Castillo Pimentel, President
Fresh Directions Dominicana
175 SW 7th Street, Suite 1505
Miami, FL 33130

Dear Mr. Manuel Castillo Pimentel:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #414653, issued November 25, 2013. 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/

Maria M. Corpuz
Team Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition 

 

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