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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pesnusan Cia Ltda Close out letter 3/21/11


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

Public Health Service
Food and Drug Administration
 Washington, DC

March 21, 2011

Mr. Nerio Nunex (Santana)
Pesnusan Cia Ltda.
KM 7.5 Via Manta Montecristi
Manta, Ecuador

Dear Mr. Nunex:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #125370, issued October 22, 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.

Dwayne L. Johnson
Compliance Officer
Office of Compliance
Center for Food Safety
   and Applied Nutrition