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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

CSL Biotherapies - Close Out Letter 8/10/12

  

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

Public Health Service
Food and Drug Administration
 

Center for Biologics Evaluation and
Research
1401 Rockville Pike
Rockville, MD 20852-1448
 

AUG 10, 2012

 

Brian McNamee
Chief Executive Officer (CEO)
CSL Biotherapies
45 Poplar Road
Parkville, Victoria 3052
Australia

Dear Mr. McNamee:  

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CBER-11-02, June 15, 2011]. 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/

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
 

 

 

cc: Clare Barker
     Senior Director of Quality
     CSL Biotherapies
     45 Poplar Road
     Parkville, Victoria 3052
     Australia
 

     Dr. Jeff Davies
     Executive Vice President  
     CSL Biotherapies
     45 Poplar Road
     Parkville, Victoria 3052
    Australia