Massachusetts Institute of Technology MIT

CLOSEOUT LETTER Massachusetts Institute of Technology MIT MARCS-CMS 663218 — January 28, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 02/12/2025 Regulated Product(s) Biologics