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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Emprede S.A. - Close Out Letter 11/30/10

  

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

Public Health Service
Food and Drug Administration
 

Washington, DC

 

 

November 30, 2010

Ms. Anita Gallardo Ossandon, CEO
Emprede SA
1212 Guillermo Cubillo St.
Tanca Marengo Km 4.5
Guyaquil, Ecuador

Dear Ms. Ossandon:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #124469, issued August 11, 2010. 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/


Priya J. Rathnam
Compliance Officer
Office of Compliance
Center for Food Safety
and Applied Nutrition


 

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