Sethi Laboratories Warning Letter Details

Summary

Sethi Laboratories was warned for offering COVID-19 antibody and antigen self-test kits directly to consumers without FDA marketing approval, clearance, or authorization, making the products adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act. The company marketed these medical devices through its website and social media platforms (Facebook, Instagram, Twitter) for home or non-healthcare settings without required premarket approval (PMA) or investigational device exemption (IDE). The products were also found to be misbranded under section 502(o) of the Act due to inadequate labeling and marketing claims related to COVID-19 mitigation, prevention, treatment, diagnosis, or cure.