Innova Medical Group, Inc. Warning Letter Details

Summary

Innova Medical Group manufactured and distributed SARS-CoV-2 antigen rapid test kits without FDA marketing approval, clearance, or authorization, making the products adulterated under federal law. FDA inspections of the company's facilities in Pasadena and Brea, California between March and April 2021 found that the INNOVA COVID-19 Self-Test Kit and related configurations were being sold commercially without required premarket approval (PMA) or investigational device exemption (IDE). The products were also misbranded because the company failed to notify FDA of its intent to introduce the devices into commercial distribution.