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Green Pharmaceutical Co. Ltd., a South Korean OTC drug manufacturer, was cited for Current Good Manufacturing Practice (CGMP) violations that rendered their drug products adulterated. The company failed to conduct required identity testing on incoming drug components, specifically high-risk shipments that required USP limit testing to ensure they met safety standards for contamination levels. The violations were identified during FDA's review of records submitted in response to a March 2023 information request pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.