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  5. Namita A. Goyal, M.D. - 677324 - 02/04/2025
  1. Warning Letters

CLOSEOUT LETTER

Namita A. Goyal, M.D. MARCS-CMS 677324 —

Product:
Biologics
Recipient:
Recipient Name
Namita A. Goyal, MD
Namita A. Goyal, M.D.

UC Irvine Health
200 S. Manchester Ave, Suite 110
Orange, CA 92868-3214
United States

namitag@hs.uci.edu
Issuing Office:
Center for Biologics Evaluation and Research (CBER)

United States

Secondary Issuing Offices

United States

Dear Dr. Goyal:

The Food and Drug Administration (FDA) has completed an evaluation of your corrective actions in response to our Warning Letter CBER-24-677324 dated October 10, 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 from your 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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