CLOSEOUT LETTER
Fresenius Medical Care Renal Therapies Group, LLC
- Recipient:
- Fresenius Medical Care Renal Therapies Group, LLC
United States
- Issuing Office:
United States
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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