Moussa C. Mansour, MD - Close Out Letter 3/7/16
- Moussa C. Mansour, MD
Department of Health and Human Services
|Public Health Service|
|Food and Drug Administration|
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
March 7, 2016
Moussa C. Mansour, MD
Massachusetts General Hospital GBR 109
55 Fruit Street
Boston, MA 02114
Dear Dr. Mansour:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated March 18, 2014. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
James Saviola, OD, CAPT USPHS
Director, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
Elizabeth Hohmann, MD
Chair and Director
Partners Human Research Committee
116 Huntington Avenue, Suite 1002
Boston MA 02116