FDA 483 - Guangxi Yulin Pharmaceutical Group Co. Ltd. - March 21, 2025

Guangxi Yulin Pharmaceutical Group Co. Ltd. in Yulin, China, was inspected by the FDA from March 17-21, 2025, for its OTC drug manufacturing operations. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory controls, unvalidated test methods, and a lack of stability testing programs. These issues indicate a severe lack of adherence to cGMP requirements, potentially impacting the identity, strength, quality, and purity of drug products distributed to the U.S. market.