Inspections, Compliance, Enforcement, and Criminal Investigations
Peslasa S.A. - Closed Out Letter 11/30/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 30, 2010
Mr. Jorge Franco
Robles 401 y Estada Coella
Dear Mr. Franco:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #126092, issued August 19, 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.
Priya J. Rathnam
Office of Compliance
Center for Food Safety
and Applied Nutrition