Delivery Method: VIA EMAIL AND UNITED PARCEL SERVICE Reference #: OBPO 20-598522 Product: Biologics
Recipient:

Recipient Name

Ernest Zeringue, MD

California IVF Fertility Center

2590 Venture Oaks Way
Suite 102 & 103
Sacramento, CA 95833-3200
United States

Issuing Office: Office of Biological Products Operations - Division II

United States

Dear Dr. Zeringue,

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 20-598522 issued February 26, 2020. 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/
Samuel Labinjo Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations Division II
Compliance Branch
[email protected]