FDA WARNING_LETTER - Guangxi Yulin Pharmaceutical Group Co. Ltd. - March 21, 2025

The FDA issued a Warning Letter to Guangxi Yulin Pharmaceutical Group Co. Ltd. following a March 17-21, 2025, inspection, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211). Consequently, their drug products are considered adulterated under the Federal Food, Drug, and Cosmetic Act. The inspection revealed multiple critical deficiencies, some of which were repeat observations from a 2016 inspection. The company consistently failed to perform identity and strength testing of active ingredients for each drug product batch before release. This fundamental lack of quality control meant drug products were distributed without adequate assurance of meeting specifications. Furthermore, Guangxi Yulin did not establish scientifically sound laboratory controls, relying on the Chinese Pharmacopeia without validating methods or demonstrating their equivalence to U.S. Pharmacopeia standards. The firm also lacked an adequate stability testing program to ensure products maintained quality throughout their labeled shelf life. A significant data integrity issue was identified: laboratory equipment, including UV-vis and IR spectroscopy, lacked audit trails and allowed analysts to alter or delete electronic raw data. This absence of appropriate computer controls undermines the integrity of testing results. The FDA deemed the company"s responses inadequate, as they lacked comprehensive corrective action plans, supporting documentation, or sufficient evidence of compliance. Due to these persistent failures, the FDA recommends Guangxi Yulin engage a qualified CGMP consultant to comprehensively evaluate its operations and implement robust corrective and preventive actions. These actions must include full pre-release testing, validated methods, a robust stability program, and stringent data integrity controls to assure the safety, effectiveness, and quality of its drug products.