Dongying Tiandong Pharmaceutical Co Ltd

CLOSEOUT LETTER Dongying Tiandong Pharmaceutical Co Ltd MARCS-CMS 506849 — January 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Dr. Lei Dong Recipient Title General Manager Dongying Tiandong Pharmaceutical Co Ltd Dongying Tiandong Pharmaceutical Co Ltd No. 1236 Nan-er Road Dongying Qu Dongying Shi Shandong Sheng , 257067 China Issuing Office: Center for Drug Evaluation and Research United States Dear Mr. Dong: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-06 dated November 10, 2016. 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 or these corrections. This letter does not relieve you or your firm from the responsibility or 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/ Rokhsana Jazi Compliance Officer Division of Drug Quality II Content current as of: 03/04/2019