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Anytime COVID Test LLC sold an unapproved COVID-19 test kit directly to consumers for at-home use without obtaining required FDA marketing approval, clearance, or authorization, making the product adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company failed to notify FDA of its intent to introduce the device into commercial distribution as required by section 510(k), resulting in the product also being misbranded under section 502(o) of the Act. The FDA identified the violation through review of multiple company websites on October 9, 2020, and April 2, 2021, and prohibited the introduction or delivery of this product into interstate commerce.