WarningLetterofJilinShulanSyntheticPharmaceuticalCoLtd(中英对照).doc

Warning Letter to Jilin Shulan Pharmaceutical Co., Ltd. During our August 24-28, 2009 inspection of your active pharmaceutical ingredient (API) manufacturing facility, Jilin Shulan Synthetic Pharmaceutical Co., Ltd. located at No. 2066 Peoples Main Road, Shulan City, Jilin Province, People’s Republic of China (PRC) 132600, an investigator from the Food and Drug Administration (FDA) identified significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs. These deviations cause your APIs to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. We have reviewed your firm’s response of October 12, 2009, and note that it lacks sufficient corrective actions. Specific deviations observed during the inspection include, but are not limited, to the following: 1. Production personnel fail to ensure that all production deviations are reported and evaluated, and that critical deviations are investigated and the conclusions are recorded. For example, during the (b)(4) of (b)(4) sub-batch (b)(4), our investigator observed that the pressure and temperature of the (b)(4) equipment fell out of range (below (b)(4) mPa and (b)(4)°C). The investigator observed no initiation of an investigation into this deviation and received no assurance that an investigation would take place. Any deviations from processing parameters should be documented and explained, whereas critical deviations should be thoroughly investigated. In addition, the investigator observed a shift change while sub-batch (b)(4) was undergoing (b)(4), in which operators from the new shift had not reported to their duty stations for more than 30 minutes after their shift began. You should have adequ