FDA EIR - CSPC Weisheng Pharmaceutical (Shijiazhuang) Co., Ltd. - September 04, 2019

This FDA Establishment Inspection Report summarizes a cGMP inspection of CSPC Weisheng Pharmaceutical Co., Limited in Shijiazhuang, China, conducted from August 29 to September 4, 2019. The focus was on the company's manufacturing of Active Pharmaceutical Ingredients (APIs), including (b)(4) USP grade, for the U.S. market.The inspection adhered to Compliance Program 7356.002F for API Process Inspection, with ICH Q7 serving as a guiding document. The company's operations fall under the purview of the Federal Food, Drug, and Cosmetic Act, necessitating compliance with current Good Manufacturing Practices (cGMPs) as detailed in 21 CFR 210 and 211. Key systems reviewed included Quality, Material, Production, and Laboratory functions.Crucially, the inspection concluded with no significant findings. No FDA-483, which typically documents deficiencies, was issued to the firm, indicating a satisfactory level of compliance. Furthermore, the FDA investigator confirmed that corrective actions taken by CSPC Weisheng in response to observations from a previous 2013 inspection were adequate. Consequently, no new regulatory actions were required from this assessment.