Nanjing Hanxin Pharmaceutical Technology Co. Ltd. – FDA Warning Letter, Nov 18, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter dated November 3, 2026, to Nanjing Hanxin Pharmaceutical Technology Co. Ltd. following a regulatory review of manufacturing records requested in November 2025. The FDA concluded that the firm’s active pharmaceutical ingredients (APIs) are adulterated because the methods and controls used in their manufacture fail to conform to Current Good Manufacturing Practice (CGMP) standards required by the Federal Food, Drug, and Cosmetic Act. A primary violation is the Quality Unit’s failure to exercise proper oversight, specifically regarding the qualification of critical raw material suppliers. The review revealed that the company sourced materials from a non-compliant subsidiary already subject to an FDA import alert. The FDA noted concerns that Nanjing Hanxin may have misidentified the actual manufacturer of these materials to bypass safety safeguards. Additionally, the firm registered products for human drug compounding that are not permitted under federal regulations. Required actions include a systemic corrective and preventive action (CAPA) plan to remediate supplier qualification, a comprehensive assessment of the Quality Unit’s authority, and the submission of stability data for all APIs. The firm must also provide a list of all drug distributions and suppliers from the last three years and notify customers who received lots produced from non-compliant materials. The FDA placed the firm’s products on Import Alert 66-40 in June 2026 and may continue to withhold approval of new applications until these deviations are fully addressed.