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  5. Chocolates Garoto S.A. - Close Out Letter 8/26/16
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Chocolates Garoto S.A.

Chocolates Garoto S.A.


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

Public Health Service
 Food and Drug Administration
College Park, MD 20740

Date  AUG 26, 2016

Mr. Fabio Battistella, Factory Manager
Chocolates Garoto S.A.
Praca Meyerfreund, 1 -Gloria
Vila Velha, Espirito Santo, Brazil 29122-900

Dear Mr. Battistella:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #472113, dated August 3, 2015. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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.



Paige E. Shelborne
Acting Branch Chief, Labeling and Dietary
Supplement Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition