Ignatius P. Godoy, M.D.

CLOSEOUT LETTER Ignatius P. Godoy, M.D. MARCS-CMS 561662 — March 06, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 03/12/2019