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LCC Ltd., a South Korean drug manufacturer, failed to meet Current Good Manufacturing Practice (CGMP) standards for finished pharmaceuticals, resulting in adulterated products that do not conform to FDA regulations. During a March 2024 inspection, the FDA identified critical violations including failure to adequately test component samples for identity, purity, strength, and quality, and failure to validate supplier test analyses at appropriate intervals—deficiencies particularly concerning given the firm's manufacture of over-the-counter products like anticavity mouthwash. Additionally, two specific products—"SOL Mouthwash, zero alcohol, frosty mint" and "Oriox Cool Breath Oral Rinse, Mild mint"—were determined to be unapproved new drugs and misbranded, making their introduction into interstate commerce prohibited under the Federal Food, Drug, and Cosmetic Act.