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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

COVI S.A.S - Close Out Letter 5/7/13

  

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

Public Health Service
Food and Drug Administration
 5100 Paint Branch Parkway
College Park, MD 20740

 

May 7, 2013


Mr. Patrice Bourigault, President
COVI S.A.S
341, Route de Clisson
St. Sebastien Sur Loire 44233
France


Dear Mr. Bourigault:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #393571, issued April 18, 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/

William Correll
Branch Director
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
      and Applied Nutrition