Warning Letter: 320-19-04 Return Receipt Requested November 29, 2018 Mr. Jun Du Executive Vice President Zhejiang Huahai Pharmaceutical Co., Ltd. Coastal Industrial Zone, Chuannan No. 1 Branch No. 9 Donghai Fifth Avenue, Linhai, Taizhou Zhejiang 317016 CHINA Dear Mr. Du: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Zhejiang Huahai Pharmaceutical Co., Ltd., located at Coastal Industrial Zone, Chuannan No. 1 Branch No. 9, Donghai Fifth Avenue, Linhai, Taizhou Zhejiang, from July 23 to August 3, 2018. This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). Because your...