FDA sends warning letter after Chinese supplier breaks GLP-1 import restrictions

 

While the manufacturer is on the list of authorized GLP-1 importers, FDA inspectors found the company relabeled APIs from another site in a potential attempt to “circumvent safeguards.”

A Chinese company has fallen afoul of the FDA’s recently introduced restrictions on GLP-1 receptor agonist imports, leading the agency to issue a warning letter over semaglutide shipments.

In September 2025, FDA acted to stop GLP-1 active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. The action created a “green list” of facilities permitted to ship GLP-1 APIs. FDA vowed to detain shipments from unverified sources as part of a push to protect U.S. patients from potentially dangerous ingredients.

As part of the action, FDA added Harbin Jixianglong Biotech to the green list, clearing the Chinese API manufacturer to export GLP-1 drugs made at its facility in Harbin, China, to the U.S. However, FDA inspectors discovered a compliance failure when they visited the manufacturing facility two months later.

Jixianglong bought semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, from a facility that is not on the green list, FDA said in its warning letter. The company allegedly labeled the API as manufactured at its facility, implying it was made at a plant on the green list, and shipped the batch to the U.S.

“FDA is concerned that identifying your firm and not the actual manufacturers may have been an attempt to circumvent safeguards associated with [the import alert] and may pose a risk to consumers of receiving substandard GLP-1 APIs,” the agency said.

Inspectors issued a Form 483 setting out their concerns, prompting a response from Jixianglong in late November. Citing high demand for semaglutide API in the U.S., the company told FDA that it “occasionally purchased the product externally for resale,” according to the agency.

The company that manufactured the semaglutide batches was not on Jixianglong’s approved supplier list, the FDA said. Jixianglong allegedly repackaged and relabeled the two batches without documentation and changed the date of manufacture. Jixianglong acknowledged lacking appropriate procedures for releasing externally purchased products and batch records for repackaging and labeling, FDA said.

While the company committed to prohibiting the sale of externally procured products, it initially failed to address FDA’s concerns about the batches already on the U.S. market. FDA recommended that Jixianglong recall the batches, leading the company to pull the API from the U.S. market in February.

FDA’s March 11 enforcement report listed Jixianglong recalls of “semaglutide, for Rx compounding use only.” The report attributed the recalls to “failing to complete process validation and bacterial endotoxin method validation before distribution.”

https://www.biospace.com/fda/fda-sends-warning-letter-after-chinese-supplier-breaks-glp-1-import-restrictions