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Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs during an FDA inspection in December 2023. The company failed to establish appropriate laboratory controls, including scientifically sound specifications and analytical testing procedures for critical quality attributes, and failed to develop proper release specifications and test procedures for over-the-counter drug products. Notably, the company's certificate of analysis for at least one OTC product listed only a single active ingredient despite the label claiming two active ingredients, indicating deficiencies in quality control and product consistency. The violations rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.