WuXi Biologics said its drug-substance and drug-product manufacturing facilities at the Wuxi Mashan site completed a two-week, unannounced FDA inspection of their compliance with good manufacturing practice requirements.
The routine inspection covered several FDA-approved products manufactured at the site, including monoclonal antibodies, bispecific antibodies, fusion proteins and enzyme products. WuXi Biologics announced the inspection result Sept. 24 but did not provide the inspection dates.
The Wuxi Mashan facility manufactures both drug substances and finished drug products. WuXi Biologics said it was the first biopharmaceutical manufacturing facility in China approved by both FDA and the European Medicines Agency for commercial production.
Over the past 13 years, the site has undergone more than 600 regulatory and client audits and supported the global launch of more than 20 biologic medicines, according to the company. WuXi Biologics reported a 100% success rate for those audits but did not define how it calculates that measure.
Across its operations, WuXi Biologics said it had completed 49 regulatory inspections as of the end of June 2026, including 22 conducted by FDA and EMA. It also reported 166 facility license approvals and more than 2,000 good manufacturing practice quality audits by clients, including more than 280 audits by European Union Qualified Persons.
The company currently operates 26 drug-substance facilities and 19 drug-product facilities across its global network.