Vivera Pharmaceuticals, Inc. Warning Letter Details

Summary

Vivera Pharmaceuticals sold COVID-19 antigen test kits (saliva and nasal versions) through their websites without FDA marketing approval, clearance, or authorization, making the products adulterated under federal law. The company also failed to submit a 510(k) premarket notification to FDA before introducing the devices into commercial distribution, constituting a misbranding violation. These unauthorized diagnostic devices were marketed for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people, which brought them under FDA's regulatory jurisdiction as medical devices.