California IVF Fertility Center

CLOSEOUT LETTER California IVF Fertility Center MARCS-CMS 598552 — August 09, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Samuel.Labinjo@fda.hhs.gov Content current as of: 08/13/2021 Regulated Product(s) Biologics