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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kirkwood, John M., M.D. Close out Letter 5/28/10


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

Public Health Service
Food and Drug Administration

May 28, 2010

John M. Kirkwood, M.D.
University of Pittsburgh Cancer Institute
Hillman Cancer Research Pavilion, Suite 1.32
5115 Centre Avenue
Pittsburgh, Pennsylvania 15213-1301

Dear Dr. Kirkwood:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-09-08 dated September 15, 2009. 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.


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


Kirk Sooter, Director
Philadelphia District, HFR-CE100
Food and Drug Administration
900 U.S. Customhouse
200 Chestnut Street
Philadelphia, Pennsylvania 19106