Harbin Jixianglong Biotech Co., Ltd.
FDA issued a warning letter to Harbin Jixianglong Biotech Co., Ltd., a Chinese manufacturer of peptide APIs including semaglutide and tirzepatide, following a November 2025 inspection. The agency found the firm purchased semaglutide API from unapproved suppliers, repackaged and relabeled it under its own name with falsified manufacturing and retest dates, and distributed it to the U.S. market — conduct FDA characterized as potentially circumventing Import Alert 66-80 safeguards. Additional violations included lack of process and cleaning validation, inadequate analytical method validation, insufficient water quality controls, and drug listing/misbranding violations. The firm was placed on Import Alert 66-40 (detention without physical examination), removed from the GLP-1 Green List, and initiated a voluntary recall of two semaglutide API batches.
Flagged claims (2)
due to high demand of semaglutide API in the U.S., you "occasionally purchased the product externally for resale."
Manufacturer: Harbin Jixianglong Biotech Co., Ltd.
Required actions (5)
On February 27, 2026, your firm was placed on Import Alert 66-40 Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs and removed from the Green List of Import Alert 66-80 Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances.
We acknowledge that on February 19, 2026, you initiated a voluntary recall of the two semaglutide API batches distributed in the United States.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence.
A risk assessment of all APIs you repackaged that are missing any required manufacturing documentation for release and distribution., notify your customers and determine if market actions, such as recall, is necessary.
Based upon the nature of the deviations identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
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