Graftys, S.A. - Close Out Letter 3/10/14
- Graftys, S.A.
Department 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
MAR 10, 2014
Cofounder and CEO
Eiffel Park - Bat C
415 rue Claude Nicolas Ledoux
Aix En Provence, France
Dear Mr. Valet:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 396846 dated June 25, 2013. 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.
William C. MacFarland
Division of Manufacturing and Quality
Office of Compliance
Center for Devices and Radiological