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  5. Richard K. Burt - Close Out Letter 12/13/16
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CLOSEOUT LETTER

Richard K. Burt


Richard K. Burt

  

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

10903 New Hampshire Avenue
Silver Spring, MD 20993 

December 13, 2016

Richard K. Burt, M.D.
Chief, Division of Immunotherapy
Northwestern University
Feinberg School of Medicine
446 East Ontario Street, Suite 1000
Chicago, Illinois 60611

Dear Dr. Burt:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-17-02 dated November 15, 2016. 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 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