FDA WARNING_LETTER - Henan Lvyuan Pharmaceutical Co., Ltd. - September 26, 2025

Henan Lvyuan Pharmaceutical Co. Ltd., based in Henan, China, received an FDA warning letter following an inspection conducted from September 22 to 26, 2025. The agency identified significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). Under the Federal Food, Drug, and Cosmetic Act, these violations classify the company"s products as adulterated. Primary concerns involve the failure to maintain buildings and equipment properly. Inspectors observed extensive corrosion on manufacturing tanks and numerous water leaks in warehouses, production, and packaging areas. Such conditions create substantial risks for microbial contamination and chemical degradation of APIs. Additionally, the company failed to maintain adequate master production and control records. Specific batch records lacked essential processing details, such as time limits and ingredient weights, making it impossible to ensure consistent product quality. The FDA also highlighted potential cross-contamination risks due to inadequate separation between different manufacturing operations. While the company responded to initial findings, the FDA deemed the response insufficient. Consequently, Henan Lvyuan must now provide a comprehensive risk assessment for all drug lots currently distributed in the United States. This must include potential customer notifications or product recalls if quality issues are found. The company is also required to implement a robust preventive maintenance program and undergo an independent, global review of its production processes and documentation. The FDA has granted the company 15 working days to respond with a detailed plan for corrective actions. Failure to address these deficiencies may result in the FDA refusing entry of the company"s products into the United States or withholding approval for new drug applications.