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  5. Ignatius P. Godoy, M.D. - 561662 - 03/06/2019
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CLOSEOUT LETTER

Ignatius P. Godoy, M.D. MARCS-CMS 561662 — Mar 06, 2019

Ignatius P. Godoy, M.D. - 561662 - 03/06/2019


Recipient:
Recipient Name
Ignatius P. Godoy, M.D.
Ignatius P. Godoy, M.D.
Ignatius P. Godoy, M.D.

16660 Paramount Boulevard
Suite 206
Paramount, CA 90723-5458
United States

Issuing Office:
Center for Biologics Evaluation and Research

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Dr. Godoy:

The Food and Drug Administration completed an evaluation of your corrective actions in response to our Warning Letter CBER-19-01 dated October 1, 2018. Based on our evaluation, it appears that you 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 the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research