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CLOSEOUT LETTER

Baxter Healthcare Corporation


Baxter Healthcare Corporation

 

  

Black HHS-Blue FDA Logo

 

 

 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

May 12, 2017

Vincent R. Marchionni, Plant General Manager
Baxter Healthcare Corporation
17511 Armstrong
Irvine, California 92614-5725

Dear Mr. Marchionni:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #07-14 dated December 19, 2013). 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,
/S/

CDR Steven E. Porter, Jr.
Los Angeles District Director