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Talk to a SpecialistTalk to a SpecialistBodywell Natural Skin Care Inc., a Canadian OTC drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of skincare products including "VivaLaCara, All Natural, DERMALERE" creams. The company failed to conduct required identity tests on drug components and did not validate or establish the reliability of component supplier test analyses at appropriate intervals, resulting in adulterated drug products. Additionally, the DERMALERE Advanced Burn and Scar Cream and Advanced Skin Cream were determined to be unapproved new drugs in violation of FDA approval requirements, making their introduction into interstate commerce illegal.