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Far East Summit LLC was cited for distributing unapproved new drugs and misbranded drugs through their website and product catalog, specifically traditional Chinese medicine products including Si Ni San, Gan Mao Ling, Guan Jie, and numerous others. The company violated federal law by making disease-treatment claims on their website and product labeling—such as "relieves cough," "resolves depression," and "disperses swelling"—that established these products as drugs requiring FDA approval rather than dietary supplements. The FDA inspection of the facility from January through February 2024 identified serious violations of the Federal Food, Drug, and Cosmetic Act based on review of the company's product catalog, order forms, and website marketing materials.