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CLOSEOUT LETTER

Edwards Lifesciences, LLC


Edwards Lifesciences, LLC

  

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

 
 Food and Drug Administration
Denver District Office
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000
 

July 6, 2016

UPS Overnight

Michael A. Mussallem
Chairman & CEO
Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614

Re: DEN-13-14-WL
 

Dear Mr. Mussallem:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter DEN-13-14-WL, dated May 24, 2013. Based on our evaluation, it appears that you have addressed the violation(s) 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/

LaTonya M. Mitchell
District Director