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  5. Gexfix SA - 01/07/2015
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Gexfix SA

Gexfix SA

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

JAN 7 2015


Giuseppe Longo
CEO and President
Gexfix SA
Av. De La Praille
50 Carouge, CH-1227

Dear Mr. Longo:

The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter, CMS #396216, dated May 15, 2013. Based on our evaluation, it appears that your firm has addressed the violations 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.

Sincerely yours,
Carl Fisher, Ph .D.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health

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