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U.S. Department of Health and Human Services

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Enforcement Actions

Beckman Coulter Inc - Close Out Letter 8/15/12

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415
 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

August 15, 2012

Mr. Thomas P. Joyce, Jr.
(Acting) President, Diagnostics Division
Beckman Coulter
Corporate Headquarters
250 S. Kraemer Boulevard
Brea, CA 92822-8000

Dear Mr. Joyce: 

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, WL # 48-11, dated 08/09/11. 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/

Alonza E. Cruse
District Director
Los Angeles District