FDA finds black mold and contamination at Chinese factories making compounded GLP-1 drug components

FDA inspection reports obtained under FOIA reveal gross contamination, including black mold, bug activity, and falsified safety documentation, at Chinese facilities Chengdu Shengnuo Biopharm and Nanjing Chengong Pharmaceutical. The factories manufacture semaglutide and tirzepatide components for unapproved compounded GLP-1 weight-loss drugs. During inspections, employees attempted to hide documents and dump samples into sinks. The FDA placed both companies on its import-alert list to block shipments.

FDA inspection findings at Chengdu Shengnuo

• ▪FDA inspectors documented black mold on equipment, bug activity in ceilings, and gross contamination on floors at a Chengdu Shengnuo Biopharm facility in August 2026.
• ▪During the August 2026 FDA inspection, Chengdu Shengnuo Biopharm employees ran from a lab to stuff documents into hall lockers, preventing inspectors from recovering all files.
• ▪FDA inspectors observed Chengdu Shengnuo Biopharm personnel pouring product samples into sinks in a seemingly coordinated effort during the August 2026 inspection.

Regulatory actions and responses for Chinese suppliers

• ▪Chengdu Shengnuo Biopharm stated in a Chinese regulatory filing that it has been diligently implementing effective measures to correct the reported problems.
• ▪The FDA placed Chengdu Shengnuo Biopharm and Nanjing Chengong Pharmaceutical on its import-alert list, enabling US border officials to detain or confiscate their incoming products.
• ▪Amphastar Pharmaceuticals spokesperson Dan Dischner stated the company holds an 11.5% minority ownership in Nanjing Hanxin Pharmaceutical Technology but does not control operations at subsidiary Nanjing Chengong.

GLP-1 shortages and compounding practices

• ▪Some drug compounders sell weight-loss copycats lacking shortage status under the legal theory that adding an ingredient like vitamin B12 allows market distribution.
• ▪Drug compounders are permitted to offer alternatives for patients unable to tolerate brand-name medications by altering formulas or dosage forms.
• ▪Semaglutide and tirzepatide fell into short supply in 2022, enabling the drug compounding industry to step in with alternative versions.
• ▪Unlike brand-name and generic medications, compounded GLP-1 drug copies do not undergo direct FDA review or approval for safety and effectiveness before sale.

Historical 2012 Compounding Pharmacy outbreak

• ▪The fatal 2012 New England Compounding Pharmacy outbreak prompted a congressional investigation and expanded FDA oversight of drug compounders.
• ▪A 2012 contamination incident involving steroid shots from New England Compounding Pharmacy infected over 700 people with meningitis and killed 64 people.