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