CLOSEOUT LETTER

Fresenius Medical Care Renal Therapies Group, LLC November 05, 2015

Recipient:: Fresenius Medical Care Renal Therapies Group, LLC; United States

Issuing Office:: United States


Department 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

Department of Health and Human Services