Are dead insects in manufacturing areas enough to disqualify a firm from the FDA’s Green List for makers of GLP-1 API?
At the moment, the identities of the companies on the Green List are not publicly available; there’s no easy way to scrutinize their safety history. PSM recently obtained FOIA-ed inspection reports of two Chinese manufacturers that GLP-1 insiders believe are on the Green List—a belief bolstered by customs releasing their shipments of semaglutide and tirzepatide after the list was instated in October 2025.
Americans should have a better understanding of what constitutes “safe enough” to get an API manufacturer on the Green List. Apparently the observations below were not enough to disqualify them. What would we find in other Green List inspection records if we knew which companies to look at?
What’s in the inspection reports?
Compounding industry experts have told us that these two companies are on the FDA’s Green List, despite problematic inspections in late 2024 and early 2025.
According to the FDA’s Imports Entry Data Search, Sinopep-Allsino Biopharmaceutical Co., Ltd has sent 328 shipments to the U.S. since late 2020. Antidiabetics (GLP-1s) start showing up in shipments in 2023. Among the FDA inspector’s observations in September 2024:
- Foreign residue on equipment that manufactured API that was marked as “CLEAN”;
- Pieces of a canvas glove left behind by machine maintenance staff in rooms marked as “Clean, Ready To use”;
- Rain water in storage rooms and water leaking in a microbiology lab.
- Live and dead insects in places they shouldn’t be.
FDA inspectors also inspected Nanjing Hanxin Pharmaceutical Technology Co., Ltd, in March 2025. Nanjing Hanxin has sent 114 shipments since 2020, including GLP-1s, peptides, and insulin products. The inspectors cited:
- Concerns with their environmental monitoring process.
- Failure to monitor and control microbial quality of water used to produce nonsterile API for the production of sterile API. Inspectors found microorganisms, presumably the unwanted kind, in quality control samples.
- Failure to label internal testing samples so that they are distinguishable from API for manufacturing and compounding.
Takeaway
Medicine safety would be significantly improved if companies on the Green List weren’t a secret. We believe the FDA should maintain a publicly available list of companies and facilities on the Green list.
Background
Last March, PSM highlighted a significant number of problem shipments of illegally manufactured raw ingredients for diabetes and weight loss medicines coming into the U.S. marked “for compounding.”
In September, FDA announced that they had added a number of manufacturers of such ingredients for diabetes and weight loss injectable compounding to a “Green List”. They said these companies met their standards for producing GLP-1 compounding ingredients. Shipments from other companies would be subject to detention without examination.