Advanced Renal Technologies Inc Mar 02, 2016

CLOSEOUT LETTER

Advanced Renal Technologies Inc - Close Out Letter 3/2/16

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Department of Health and Human Services
	Food and Drug Administration Seattle District Pacific Region 22215 26th Ave SE, Suite 210 Bothell, WA 98021 Telephone: 425-302-0340         FAX: 425-302-0402

March 2, 2016
 

OVERNIGHT DELIVERY
SIGNATURE REQUIRED

Michael D. Fulton
President and Managing Director
Advanced Renal Technologies, Inc.
40 Lake Bellevue Drive, Suite 100
Bellevue, Washington 98005

Dear Mr. Fulton,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 14-12. Based on our evaluation, it appears 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,

/S/

Miriam R. Burbach
District Director


cc: Robin Callan, Vice President and Chief Operating Officer
     Advanced Renal Technologies, Inc.
     40 Lake Bellevue Drive, Suite 100
     Bellevue, Washington 98005

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