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Biopolygen Corp. was warned for distributing three COVID-19 self-detection test kits (COVIGEN AG-1, COVIDEX AB-1, and COVID-19 Antigen and Antibody Combo Set) without FDA marketing approval, clearance, or authorization, rendering the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company failed to submit required premarket approval (PMA) or investigational device exemption (IDE) applications and did not provide the mandatory 510(k) notification before introducing the devices into commercial distribution, which also violated section 502(o) regarding misbranding. The FDA identified these violations through website reviews conducted on January 7, February 26, and June 30, 2021, and prohibited the introduction or delivery of these products into interstate commerce.