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Talk to a SpecialistTalk to a SpecialistCosmo Bio Co., Ltd., a South Korean OTC drug manufacturer, failed to conduct appropriate laboratory testing and assay analysis before releasing batches of Georganic Propolis Acne Care Serum, violating Current Good Manufacturing Practice (CGMP) regulations under 21 CFR 211.165(a). The product was found to be adulterated due to inadequate manufacturing controls and methods, and was also deemed an unapproved new drug that was misbranded. These violations rendered the product subject to regulatory action and prohibited from introduction into interstate commerce.