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CLOSEOUT LETTER

Maquet Cardiopulmonary Ag 04/04/2016

Maquet Cardiopulmonary Ag - Close Out Letter 4/4/16

Maquet Cardiopulmonary Ag
  

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

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

APR 4, 2016

Mr. Harmut Schmidt
President
Maquet Cardiovascular AG
Kehler Strasse 31
D-76437 Rastatt
Germany

Dear Mr. Schmidt:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #438658, dated December 4, 2014. 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,

/S/

Keisha R. Thomas, M.S., M.H.S.
Acting Director
Division of Premarket and Labeling
   Compliance
Office of Compliance
Center for Devices and
   Radiological Health