The US regulator has placed two Chinese manufacturers on an import alert after inspections found sanitation failures and inadequate checks on suppliers linked to ingredients used in compounded weight-loss injections.
The US Food and Drug Administration has moved against two Chinese ingredient makers after inspections it said uncovered serious manufacturing lapses linked to active ingredients used in compounded GLP-1 weight-loss medicines. According to Bloomberg’s reporting on FDA records, inspectors found black mould, contaminated surfaces and insect activity at Chengdu Shengnuo Biopharm, while a separate inspection at Nanjing Chengong Pharmaceutical raised questions about how the company verified ingredients bought from other manufacturers.
The FDA’s action matters because the agency uses import alerts to block products from firms with known compliance problems without physically checking every shipment. On its website, the regulator says that import alerts can trigger detention without physical examination, a tool known as DWPE, when violations suggest a product may not meet US standards. Chengdu Shengnuo and Nanjing Chengong now appear on Import Alert 66-40, which covers firms that have not met current good manufacturing practice requirements.
The findings come as the FDA has tightened scrutiny of GLP-1 supply chains more broadly. In September 2025, the agency launched a separate “green list” alert aimed at keeping potentially unsafe GLP-1 active pharmaceutical ingredients from unverified foreign sources out of the US market, and in its latest revision of that system it said it had reviewed 48 GLP-1 manufacturing sites, finding 21% to be non-compliant under the relevant statutory provisions.
GLP-1 drugs such as semaglutide and tirzepatide are the active ingredients in branded medicines including Ozempic, Wegovy, Mounjaro and Zepbound, but compounded versions are different products and are not individually approved by the FDA before sale. That distinction is important: the import alerts do not prove that every batch made by the two Chinese firms was contaminated, nor that every compounded injection using those ingredients is unsafe, but they do underline how much depends on sanitation, supplier checks and reliable records throughout the manufacturing chain.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
