Center for Reproductive Health Joliet IVF LLC

CLOSEOUT LETTER Center for Reproductive Health Joliet IVF LLC April 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Center for Reproductive Health Joliet IVF LLC United States Issuing Office: United States Chicago District Office 550 W. Jackson Blvd., 15th Floor Chicago, IL 60661 VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED April 09, 2018 R. Scott Springer, DO, Medical Director Center for Reproductive Health Joliet IVF LLC 2246 Weber Rd. Crest Hill, IL 60403 Dear Dr. Springer, The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, WL #OBPO 17-01 issued July 06, 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/ Sam Labinjo Compliance Officer U.S. Food and Drug Administration Office of Biological Products Operations Division II, Compliance Branch Tel: 312-596-4254 Samuel.Labinjo@fda.hhs.gov Content current as of: 04/20/2018