Louisville Reproductive Center

CLOSEOUT LETTER Louisville Reproductive Center MARCS-CMS 533267 — March 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Louisville Reproductive Center United States Issuing Office: United States Office of Biological Products Operations Division II Compliance Branch VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED March 05, 2018 Robert J. Homm, MD Medical Director Louisville Reproductive Center Louisville, KY 40207-4733 Dear Dr. Homm, The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 17-03 issued August 29, 2017. Based on our evaluation, it appears that you have addressed the violations 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/ Dan Cline Captain, USPHS (Ret) Compliance Officer U.S. Food and Drug Administration Office of Biological Products Operations Division II, Compliance Branch Tel: 949-608-4433 Daniel.Cline@fda.hhs.gov Content current as of: 03/27/2018