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CLOSEOUT LETTER

Baxter Healthcare Renal Div Feb 10, 2017

Baxter Healthcare Renal Div - Close Out Letter 2/10/17


Baxter Healthcare Renal Div

 

  

Black HHS-Blue FDA Logo

 

 

 
Chicago District Office
550 W. Jackson Blvd., 15th Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187 

February 10, 2017
 

José E. Almeida
Chief Executive Officer
Baxter International
1 Baxter Parkway
Deerfield, IL 60015

Dear Mr. Almeida:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-07-10 dated June 03, 2010. 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/

William R. Weissinger
District Director