FDA WARNING_LETTER - Harbin Jixianglong Biotech Co., Ltd. - November 07, 2025

Harbin Jixianglong Biotech Co., Ltd. received an FDA warning letter following an inspection from November 3 to 7, 2025, at its facility in Harbin, China. The agency identified significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering the products adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. A major violation involved the quality unit’s failure to oversee operations; the company purchased semaglutide from unapproved suppliers and relabeled it as its own production, potentially to circumvent import restrictions. Additionally, the firm changed manufacturing and retest dates without supporting data. Other critical issues included distributing APIs without validated manufacturing processes, inadequate cleaning procedures for shared equipment, and the use of unvalidated analytical methods for testing drug purity and potency. The FDA also noted that the facility failed to monitor water used in manufacturing for microbial contamination and neglected to properly register its establishment or list its products. In response, the FDA requires a comprehensive risk assessment of all distributed products, a corrective and preventive action (CAPA) plan for supplier qualification, and a full remediation of the quality unit. Harbin Jixianglong must provide validated protocols for manufacturing, cleaning, and laboratory testing. The agency strongly recommends hiring an independent consultant to assist in meeting compliance standards. While the company has initiated a voluntary recall of two semaglutide batches, the FDA maintains that systemic improvements are necessary to ensure the safety and quality of future products.