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CLOSEOUT LETTER

Carefusion 2200 Inc Sep 17, 2015

Carefusion 2200 Inc - Close Out Letter 9/17/15


Carefusion 2200 Inc

  

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

Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

September 17, 2015

VIA UPS Next Day

Mr. Vincent A. Forlenza
Chairman, President, and Chief Executive Officer
Becton Dickinson
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Mr. Forlenza:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-9-14, dated June 6, 2014. 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/

William R. Weissinger
District Director


cc: Mr. Joseph Hutson
     WW Vice President, Quality Management and Respiratory Solutions
     CareFusion 2200, Inc.
     75 North Fairway Drive
     Vernon Hills, IL 60061