Baltimore Beauty Security Square Mall Warning Letter Details

Summary

Baltimore Beauty Security Square Mall was cited for offering GenBody COVID-19 antigen and antibody test kits directly to consumers without FDA marketing approval, clearance, or authorization. The products were deemed adulterated because the company lacked an approved Premarket Approval (PMA) application or Investigational Device Exemption (IDE), and misbranded because the firm failed to submit the required 510(k) notification before introducing the devices into commercial distribution. The FDA determined that the sale and distribution of these COVID-19 test kits violated the Federal Food, Drug, and Cosmetic Act and constituted prohibited acts under interstate commerce regulations.