Yuki Gosei Kogyo Co., Ltd.

CLOSEOUT LETTER Yuki Gosei Kogyo Co., Ltd. MARCS-CMS 547871 — November 16, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 320-18-63 Product: Drugs Recipient: Recipient Name Mr. Makoto Kito, Ph.D. Recipient Title General Manager Yuki Gosei Kogyo Co., Ltd. Joban Factory 788, Ochiai, Joban Nishigo-machi Iwaki-shi , Fukushima 972-8316 Japan Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Kito: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-18-63 dated July 17, 2018. Based on our evaluation, it appears that you have addressed the deviations 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 FDA 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Christina Alemu-Cruickshank Compliance Officer Division of Drug Quality I Content current as of: 11/29/2021 Regulated Product(s) Drugs