Vivera Pharmaceuticals, Inc. – FDA Warning Letter, Aug 10, 2021
On July 26, 2021, the FDA issued a Warning Letter to Vivera Pharmaceuticals regarding the sale of "COVxRDA Saliva Antigen Test" and "COVx-RDA Nasal Antigen Test" (COVxRDA Antigen Test Kits) on their websites, https://viveracovid19.com/covx-rda/ and https://viverapharmaceuticals.com/products/. The FDA reviewed these websites on January 13, March 3, and April 1, 2021.
The FDA determined that the COVxRDA Antigen Test Kits are intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure, classifying them as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h).
The products were offered for sale without FDA marketing approval, clearance, or authorization. Consequently, the COVxRDA Antigen Test Kits are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), due to the lack of approved premarket approval (PMA) or investigational device exemption (IDE) applications. They are also misbranded under section 502(o) of the
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