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North American Diagnostics, LLC manufactured and distributed multiple brands of SARS-CoV-2 antigen rapid test kits without obtaining required FDA marketing approval, clearance, or authorization, making the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. During a June 2022 inspection, FDA investigators documented that the company had distributed the COVID-19 test kits into U.S. commerce without the required premarket approval (PMA) or investigational device exemption (IDE), violations the company acknowledged in its official response. The products were also found to be misbranded under section 502(o) of the Act and lacked proper regulatory authorization, representing a significant compliance failure for a medical device manufacturer.