The FDA issued a warning letter to a Chinese supplier, Harbin Jixianglong Biotech, after inspectors alleged the company used labeling practices that may have circumvented the agency’s GLP-1 import restrictions. FDA scrutiny followed the creation of a “green list” of facilities authorized to ship GLP-1 active pharmaceutical ingredients into the U.S. According to the FDA, Jixianglong bought semaglutide API from a facility not on the green list and allegedly relabeled it as manufactured at its authorized site before shipping batches to the U.S. The agency cited gaps in batch documentation and procedures for releasing externally procured products and stated that concerns about the manufacturing identity could put U.S. consumers at risk of substandard APIs. The enforcement action is likely to increase compliance pressure across the GLP-1 supply chain as demand continues and regulatory scrutiny targets sourcing traceability.
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