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Talk to a SpecialistTalk to a SpecialistWuhu Nuowei Chemistry Co., Ltd., a Chinese active pharmaceutical ingredient (API) manufacturer, was found to have produced adulterated drugs that failed to meet Current Good Manufacturing Practice (CGMP) standards during an FDA inspection in September 2024. The company's primary violations included failing to establish scientifically sound test methods and appropriate specifications for impurity analysis of its APIs, relying instead on Chinese Pharmacopeia methods without demonstrating equivalence to or superiority over United States Pharmacopeia (USP) compendial standards. Additionally, the manufacturer did not establish adequate impurity specifications for its products supplied to U.S. drug manufacturers, resulting in APIs that did not conform to established standards of quality and purity as required by the Federal Food, Drug, and Cosmetic Act.