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Surgenex LLC MARCS-CMS 615254 —

Delivery Method:
Via Email

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

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.

Amy Graf
Compliance Officer

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