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Copan Italia

Copan Italia

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
Document Control Center - W066-G609
Silver Spring, MD 20993-0002

FEB 11, 2015


Daniel Trivia
Managing Director
Copan ltalia
Via Perotti, 10
25125 Brescia, Italy

Dear Mr. Trivia:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #303078, dated May 14, 2012. Based on our evaluation, it appears that you have 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.



Alberto Gutierrez
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health

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