The STA Pharmaceutical Co., Ltd. Active Pharmaceutical Ingredient (API) manufacturing facility at Jinshan in Shanghai, China, has successfully passed its fourth inspection from the U.S. Food and Drug Administration (FDA)—with no Form 483s issued. The site previously passed three FDA inspections in 2013, 2014 and 2016. STA Pharmaceutical, also referred to as WuXi STA, is a subsidiary of…
WuXi STA Changzhou Site Passes First U.S. FDA Inspection
STA Pharmaceutical Co., a subsidiary of WuXi AppTec, announces that its active pharmaceutical ingredient (API) R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from the FDA—with no Form 483s issued. This is the first time that WuXi STA’s Changzhou facility has been inspected by the FDA. WuXi STA has already passed…