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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Dornier Medtech Systems GmbH - Close Out Letter 07/05/2012


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

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

JUL 05 2012

John S. Hoffer
Vice President
Quality, Regulatory, Clinical
Dornier MedTech America, Inc.
1155 Roberts Boulevard
Suite 100
Kennesaw, Georgia 30144

Dear Mr. Hoffer:

The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter (CMS Case #203432, dated August 26, 2011 ). 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.

Sincerely yours,


Anastacia M. Bilek, Ph.D.
Division of Enforcement A
Office of Compliance
Center for Devices and
Radiological Health