U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Moussa C. Mansour, MD - Close Out Letter 3/7/16
  1. Warning Letters

CLOSEOUT LETTER

Moussa C. Mansour, MD


Moussa C. Mansour, MD

  

Department of Health and Human Services' logoDepartment 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.


Sincerely yours,

/S/

James Saviola, OD, CAPT USPHS
Director, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
    Radiological Health


cc:
Elizabeth Hohmann, MD
Chair and Director
Partners Human Research Committee
116 Huntington Avenue, Suite 1002
Boston MA 02116