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Orvic dba Webstore-USA sold unapproved COVID-19 antibody test kits directly to consumers through their website without FDA marketing authorization, making the product adulterated under federal law. The company failed to obtain required premarket approval (PMA), investigational device exemption (IDE), or 510(k) notification before commercializing the serology test, violating multiple sections of the Federal Food, Drug, and Cosmetic Act. The FDA identified the violation during website reviews in August 2020 and January 2021, during the height of the COVID-19 pandemic when unauthorized diagnostic devices posed particular public health risks.