INCYTO CO., LTD.

CLOSEOUT LETTER INCYTO CO., LTD. MARCS-CMS 497916 — October 25, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Shane Cho Recipient Title Chief Executive Officer INCYTO CO., LTD. 112, Seonggeo-Gil Seonggeo-Eup Seobuk-gu Cheonan-si Chungcheongnam-do 31044 South Korea Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Cho: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS#497916] dated September 8, 2016. 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/ Scott Gonzalez Acting Deputy Director for Patient Safety and Product Quality Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health CC (US Agent): Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 Content current as of: 11/01/2018 Regulated Product(s) Medical Devices