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CLOSEOUT LETTER

Compumedics Germany Gmbh 02/02/2017

Compumedics Germany Gmbh - Close Out Letter 2/2/17


Compumedics Germany Gmbh

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993

VIA UPS

February 2, 2017

Christoph Witte
General Manager and CEO
Josef-Schüttler-Straße 2
78224 Singen
Germany

RE: FDA Reference Number COR16000605

Dear Mr. Witte:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated August 1, 2012. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
/S/

Alberto Gutierrez
Director
Office of In Vitro Diagnostics and
    Radiological Health
Center for Devices and
    Radiological Health