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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aesculap AG - Close Out Letter 11/13/13


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

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


November 13, 2013

Mr. Konrad Kobel
Vice President, Quality Management/Regulatory Affairs
Aesculap AG
Postfach 40
Am-Aesculap Platz
78532 78501 Tuttlingen

Dear Mr. Kobel:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 205233 dated September 26, 2011. 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.




William C. MacFarland
Division of Enforcement B
Office of Compliance
Center for Devices and Radiological