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Curasan AG, Frankfurt Facility MARCS-CMS 534581 —

Medical Devices

Recipient Name
Mr. Michael Schlenk
Recipient Title
Chief Executive Officer
Curasan AG, Frankfurt Facility

Lindigstrse 4
63801 Kleinostheim

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Mr. Schlenk:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #534581, dated August 23, 2017). 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.

Keisha R. Thomas, MS, MHS, RAC
Deputy Director
Division of Premarket and Labeling Compliance
Office of Compliance
Center for Devices and Radiological Health

Ray Shane
3200 Chapel Hill-Nelson Blvd.
Suite 201
Research Triangle Park, NC 27709

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