Surgenex LLC

CLOSEOUT LETTER Surgenex LLC MARCS-CMS 615254 — September 20, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Biologics Recipient: Recipient Name Abel R. Bullock/Mark A. Schallenberger Recipient Title Chief Executive Officer & Owner/Chief Operations Officer Surgenex LLC 15444 N 76th Street Suite 110 Scottsdale , AZ 85260 United States abel.bullock@surgenex.com mark.schallenberger@surgenex.com Issuing Office: Office of Biological Products Operations – Division 2 United States Dear Messrs. Bullock and Schallenberger: The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter # OBPO 21-615254 issued November 15, 2021. Based on our evaluation, it appears that you have addressed the violation(s) 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 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 and your firm 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/ Amy Graf Compliance Officer Content current as of: 09/29/2023 Regulated Product(s) Biologics