Chongqing Pharma Research Institute Co., Ltd.

CLOSEOUT LETTER Chongqing Pharma Research Institute Co., Ltd. MARCS-CMS 515080 — March 09, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Mr. Leng Minghui Recipient Title Chairman Chongqing Pharma Research Institute Co., Ltd. No. 565 Tushan Rd. Nanan District Nan'an Qu Chongqing Shi , 400061 China Issuing Office: Center for Drug Evaluation and Research | CDER 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Leng: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-24 dated February 14, 2017. 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/ Maan Abduldayem Branch Chief, GCB2 Division of Drug Quality I Content current as of: 03/12/2020