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Talk to a SpecialistTalk to a SpecialistHangzhou Glamcos Biotech Co., Ltd., an OTC drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their drug products adulterated, including failures in methods, facilities, and controls for manufacturing, processing, packing, and holding. The company's "disinpro multi-purpose ANTIBACTERIAL WIPES" product was identified as an unapproved new drug introduced into interstate commerce without required FDA approval, while both this product and "Antibacterial Wet Wipes" were found to be misbranded in violation of labeling requirements. These violations collectively violated multiple sections of the Federal Food, Drug, and Cosmetic Act concerning drug adulteration, unapproved drug marketing, and misbranding.