WuXi STA: Shanghai site passes FDA inspection
WuXi STA has announced its its Waigaoqiao site in Shanghai, China, has passed the first drug product pre-approval inspection (PAI) by the US Food and Drug Administration (FDA). During the five-day inspection in October, the inspector assessed the manufacturing facility equipment, laboratories, and other systems.
Minzhang Chen, CEO of WuXi STA, said of the successful inspection, “It is another milestone that the site starts to provide commercial drug product manufacturing services to the US market. With our industry-leading global CMC platform and proven quality system, we strive to empower more partners to accelerate their innovative medicines to market for patients worldwide.”
