Delivery Method: Via Email Product: Biologics Recipient:

Recipient Name

Martin D. Bastuba, M.D.

Recipient Title

Owner/Medical Director

Sperm Bank, Inc. dba Fertility Center of California

6699 Alvarado Road, Suite 2208
San Diego, CA 92120
United States

[email protected] Issuing Office: Center for Biologics Evaluation and Research (CBER)

United States

Secondary Issuing Offices

Dear Dr. Bastuba:

The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter CBER 25-694273 dated February 14, 2025. 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 Act(s) 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/
Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research