FDA issued a warning letter to Harbin Jixianglong Biotech after inspectors alleged the company attempted to circumvent recently introduced GLP-1 receptor agonist import restrictions. The regulator said that although the manufacturer was listed among authorized importers, inspectors found semaglutide active pharmaceutical ingredient batches were relabeled and shipped from processes tied to an unapproved source. According to FDA, the company bought semaglutide from a facility not on the “green list,” then allegedly relabeled the API as manufactured at the green-listed plant, including changes to batch manufacture dates. FDA also cited missing documentation and batch record issues around repackaging and labeling. The FDA’s 2025 action created a framework intended to detain shipments from unverified foreign sources, with specific facilities cleared to export GLP-1 APIs. FDA said it remained concerned that identifying the firm rather than the actual manufacturers “may pose a risk to consumers of receiving substandard GLP-1 APIs.” The case highlights how quickly GLP-1 supply-chain compliance has become a regulatory flashpoint, particularly as demand for semaglutide continues to strain manufacturing and distribution networks.