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  5. George C. Velmahos, M.D., Ph.D. - 01/03/2014
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George C. Velmahos, M.D., Ph.D.

George C. Velmahos, M.D., Ph.D.

United States

Issuing Office:

United States


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

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


January 3, 2014

George C. Velmahos, M.D., Ph.D.
Chief of Trauma, Emergency Surgery, and Surgical Critical Care
Massachusetts General Hospital
165 Cambridge Street, Suite 810
Boston, Massachusetts 02114

Dear Dr. Velmahos:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter CBER-14-01 dated November 29, 2013. 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.




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