WuXi STA passes first US FDA drug product pre-approval inspection at its Shanghai Waigaoqiao site

WuXi STA today said that its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection (PAI) by the US Food and Drug Administration (FDA).

During the five-day inspection from 22nd to 26th October, 2021, the FDA inspector conducted a comprehensive onsite assessment, including manufacturing facility and equipment, laboratories, quality management system, tablet production, material handling, computer control systems and data integrity. Within the same week, the site also successfully passed two additional drug product PAIs by the China NMPA for two innovative drugs from its partners. Three successful drug product PAIs during one single week is a testimony to WuXi STA’s robust and reliable quality system, the company said in a statement.

It said that WuXi STA has passed over 40 inspections from all major regulatory agencies including the US FDA, EMA, China NMPA and Japan PMDA. All eight sites across North America, Europe and Asia, follow the same quality system ensuring high-quality products manufactured for its partners worldwide.