CLOSEOUT LETTER

Trokamed GmbH May 18, 2016

Recipient:: Trokamed GmbH; United States

Issuing Office:: United States


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

MAY 18 2016

Karlheinz Trӧndle
General Manager and CEO
Trokamed GmbH
Kleine Breite 17
78187 Geisingen
Germany

Dear Mr. Trӧndle:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #414184 dated November 22, 2013). 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,

/S/

Carl Fischer, Ph.D.
Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health

cc:
U.S. Agent
Dagmar Maeser
Business Support International
1350 Avenue of the Americas, 2nd Floor
New York, New York 10019

Department of Health and Human Services