Zhejiang Tianyu Pharmaceutical Co Ltd

CLOSEOUT LETTER Zhejiang Tianyu Pharmaceutical Co Ltd MARCS-CMS 631054 — February 28, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3010972581 Product: Drugs Recipient: Recipient Name Mr. Tu Yongjun Recipient Title President and Founder Zhejiang Tianyu Pharmaceutical Co Ltd Jiangkou Development Zone Huangyan Qu Taizhou Shi Zhejiang Sheng , 318020 China Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Youngjun: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-22-23 dated August 17, 2022. 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/ Sai S. Dharmaraj Compliance Officer Division of Drug Quality I Content current as of: 03/11/2025 Regulated Product(s) Drugs