Zhejiang Hisoar Pharmaceutical Co. Ltd.

CLOSEOUT LETTER Zhejiang Hisoar Pharmaceutical Co. Ltd. MARCS-CMS 486933 — June 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Zhejiang Hisoar Pharmaceutical Co. Ltd. United States Issuing Office: United States 10903 New Hampshire Avenue Silver Spring, MD 20993 June 5, 2018 Hongming Li Executive VP, Pharmaceutical Division CEO Zhejiang Hisoar Phannaceutical Co., Ltd. No. 100 Waisha Branch Road Jiaojiang Taizhou, Zhejiang 318000 China Reference: FEI 3003735151 Dear Mr. Li: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-16-26 dated August 11, 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 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/ Daniel W. Brisker Compliance Officer Division of Drug Quality II Content current as of: 06/11/2018