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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Children's Hospital Assoc. Transfusion Medicine Services - Close Out Letter 8/8/11

  

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

Public Health Service
Food and Drug Administration
 

Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100
 

August 08, 2011

Mr. Edmund Orsini, M.D.
University of Colorado Denver
The Children's Hospital Association
Transfusion Medical Service
13123 East 16th Avenue, B120
Aurora, CO 80045

Dear Dr. Orsini:

The Food and Drug Administration has completed an evaluation of the Children's Hospital Association Transfusion Medical Service and donor center's corrective actions in response to our Warning Letter DEN-10-10 dated April 08, 2010. 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 transfusion medical service/donor center 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/

Karen S. Kreuzer .
Acting Denver District Director