Takeda Pharmaceutical Company Limited

CLOSEOUT LETTER Takeda Pharmaceutical Company Limited MARCS-CMS 603596 — October 13, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Reference #: 3004664162 Product: Drugs Recipient: Recipient Name Mr. Christophe Weber Recipient Title President and CEO Takeda Pharmaceutical Company Limited Tokyo Head Office 2-1-1, Nihonbashi-Honcho Chuo-ku Tokyo 103-8668 Japan Issuing Office: Center for Drug Evaluation and Research | CDER United States Dear Mr. Weber: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-37 dated June 9, 2020. 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 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 violations be observed during a subsequent inspection or through other means. Sincerely, /S/ for Rafael Arroyo Compliance Officer Division of Drug Quality I Content current as of: 02/02/2022 Regulated Product(s) Drugs