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  5. Fresenius Medical Care Renal Therapies Group, LLC - Close Out Letter 11/5/15
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CLOSEOUT LETTER

Fresenius Medical Care Renal Therapies Group, LLC


Fresenius Medical Care Renal Therapies Group, LLC

  

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

 
 Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

November 5, 2015

Mr. Ronald J. Kuerbitz
Chief Executive Officer
Fresenius Medical Care – North America
920 Winter Street
Waltham, MA 02451-1521


Dear Mr. Kuerbitz:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated September 15, 2010. 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/

Karen Archdeacon
Compliance Officer
New England District Office
U.S. Food and Drug Administration


Cc: Mr. Robert M. Powell, Jr.
      Chief Executive Officer
      Fresenius Medical Care AG & Co. KGaA
      920 Winter Street
      Waltham, MA 02451-1521