Strong Fertility Center

CLOSEOUT LETTER Strong Fertility Center MARCS-CMS 593262 — December 11, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Reference #: OBPO 20-593262 Product: Biologics Recipient: Recipient Name Kathleen Hoeger, MD Recipient Title Director of Tissue Bank Operations Strong Fertility Center 500 Red Creek Drive Suite 220 Rochester , NY 14623-4285 United States Issuing Office: Office of Biological Products Operations – Division I United States Dear Dr. Hoeger: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #OBPO 20-593262 dated October 29, 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/ Elizabeth Waltrip Program Division Director Content current as of: 12/22/2020 Regulated Product(s) Biologics