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CLOSEOUT LETTER

Massachusetts Institute of Technology MIT MARCS-CMS 663218 —

Product:
Biologics
Recipient:
Recipient Name
Dr. Leigh M. Firn MD
Massachusetts Institute of Technology MIT

Committee on the Use of Humans as Experimental Subjects (COUHES)
77 Massachusetts Avenue, Building E25, Room 143B
Cambridge, MA 02139-4301
United States

lfirn@mit.edu
Issuing Office:
Center for Biologics Evaluation and Research

United States

Secondary Issuing Offices

United States

Dear Dr. Firn:

The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-24-663218 dated June 21, 2024. 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 to take all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. The Agency expects you and your firm to continuously comply with the law and will monitor your state of compliance.


Sincerely,
/S/
Melissa J. Mendoza, JD
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

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