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Extrapharmacy.ru, a Russian online pharmacy, was found selling unapproved and misbranded drug products to U.S. consumers, including products claiming to treat or prevent COVID-19 as well as other diseases such as systemic lupus erythematosus, rheumatoid arthritis, and malaria. These products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act by being introduced into interstate commerce without FDA approval, and violated section 502 by being misbranded. The FDA took particular concern given the active public health emergency declaration for COVID-19 at the time of the inspection on December 13, 2021, and emphasized the inherent risks to consumers purchasing unapproved and misbranded drugs.