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WuXi STA Passes First U.S. FDA PAI at Waigaoqiao Site

Included manufacturing facility, equipment, labs, quality management system, tablet production, material handling, computer control systems, and data integrity.

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By: Kristin Brooks

Managing Editor, Contract Pharma

WuXi STA’s Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection (PAI) by the U.S. FDA.   The FDA conducted a 5-day, comprehensive inspection onsite including manufacturing facility and equipment, labs, quality management system, tablet production, material handling, computer control systems, and data integrity. The site also successfully passed two additional drug product PAIs by the China NMPA for two innovative drugs from its partners.   Wu...

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