Delivery Method: Via Email Product: Biologics Recipient:

Recipient Name

Dr. Omid A. Khorram

Recipient Title

Medical Director

University Fertility Laboratory, Inc.

23550 Hawthorne Blvd., Suite 210
Torrance, CA 90505
United States

[email protected] Issuing Office: Division of Biological Products Operations II

United States

Dear Dr. Khorram:

The Food and Drug Administration has completed evaluation of your corrective actions in response to our Warning Letter # OBPO 19-006 issued May 30, 2019. 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