W.H.P.M, Inc. Warning Letter Details

Summary

W.H.P.M, Inc. distributed unapproved COVID-19 test kits (First Sign and COVISURE branded antigen test kits) without obtaining FDA marketing approval, clearance, or authorization, making the products adulterated under federal law. The company failed to submit required premarket approval (PMA) applications or investigational device exemption requests, and did not notify FDA of its intent to introduce the devices into commercial distribution as mandated by section 510(k). These violations rendered the products both adulterated and misbranded, with their introduction into interstate commerce prohibited by the Federal Food, Drug, and Cosmetic Act.