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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Beckman Coulter, Inc. - Close Out Letter 2/3/14

  

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


Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 

February 3, 2014


Mr. Scott Cundy, President
Beckman Coulter, Inc.
1000 Lake Hazeltine Drive
Chaska, MN 55318-1084


Dear Mr. Cundy:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter of June 21, 2010. Based on our evaluation, it appears that you have addressed the violation 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/

Alberto Gutierrez, Ph.D.
Director
Office of In-Vitro Diagnostic and
   Radiological Health
Center for Devices and Radiological
   Health