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Talk to a SpecialistTalk to a SpecialistShantou S.E.Z. Baojie Industry Co., Ltd., a Chinese pharmaceutical manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter drug products. The company failed to adequately test incoming components for identity and quality specifications and instead relied on suppliers' certificates of analysis without establishing the reliability of those suppliers' testing at appropriate intervals, violating 21 CFR 211.84(d)(1) and (d)(2). These manufacturing control failures rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act. The violations were identified during an FDA inspection conducted August 26-30, 2024, with the company's response received on September 11, 2024.