WuXi Biologics Manufacturing Facilities Successfully Complete FDA GMP Inspection

WuXi Biologics has announced that its drug-substance and drug-product manufacturing facilities at the Wuxi Mashan site in China successfully completed a two-week inspection conducted by the United States Food and Drug Administration (FDA).

According to the company's announcement, the inspection was unannounced and assessed manufacturing operations associated with several products already approved by the FDA. The products covered during the inspection included monoclonal antibodies, bispecific antibodies, fusion proteins and enzyme-based medicines.

FDA inspections of pharmaceutical manufacturing facilities examine whether operations comply with applicable current Good Manufacturing Practice (cGMP) requirements. Such inspections can involve areas including manufacturing processes, quality systems, documentation, facility controls and other aspects of pharmaceutical production.

WuXi Biologics stated that the successful completion of the inspection supports continued commercial manufacturing and supply of products intended for the US market. The company also described the outcome as another regulatory milestone for its Wuxi manufacturing operations.

The Mashan facilities form part of WuXi Biologics' manufacturing network for biological medicines, providing capabilities covering both drug-substance and drug-product production. The company said the latest inspection involved manufacturing activities for multiple commercial products rather than a single medicine.

The FDA's inspection of the site is part of the regulatory oversight applied to facilities manufacturing medicines for the US market. Successful completion of an inspection provides information about a facility's compliance status at the time of the inspection and forms part of the broader regulatory framework governing pharmaceutical manufacturing. 

24-09-2026