FDA flags mold and contamination at Chinese plants making compounded weight-loss drug ingredients

FDA investigators documented black mold on machinery and severe floor contamination at Chengdu Shengnuo Biopharm in southwest China and at Nanjing Chengong Pharmaceutical on the east coast. Inspectors also uncovered evidence of falsified records, concealed documents, and deliberate disposal of product samples, as well as insect activity in the facilities. Both plants produce semaglutide and tirzepatide, the active ingredients used in popular weight-loss drugs from Novo Nordisk and Eli Lilly, for custom compounded versions that have not been reviewed for safety.

The agency added the two companies to its import-alert list, effectively barring their products from U.S. entry. Amphistar Pharmaceuticals holds a minority stake in the parent of Nanjing Chengong but does not control its operations. Experts warned the conditions could lead to a serious safety incident for patients relying on these unapproved compounds.