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AmLion Toothpaste Mfg. Sdn. Bhd., a Malaysian manufacturer of over-the-counter toothpaste products including children's formulations, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company's primary violations included failure to conduct identity testing on incoming components before manufacturing, inadequate supplier qualification, and failure to validate and establish the reliability of component suppliers' test analyses at appropriate intervals. Instead of performing required testing, the company relied solely on supplier questionnaires reviewed by purchasing personnel rather than the quality unit, and lacked documented supplier approval through proper quality channels. The FDA conducted an inspection from July 10-14, 2023, and issued the warning letter on November 17, 2023, following the company's August response to the inspection findings.