W.H.P.M, Inc.

Warning LetterClosed

Dr. John Wan President & CEO W.H.P.M, Inc. 5358 Irwindale Ave., Suite B Irwindale , CA 91706 United States johnwan@whpm.comIssued Jun 30, 2022Office of Medical Device and Radiological Health Division 3

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Letter Details

Firm: W.H.P.M, Inc.
Location: Dr. John Wan President & CEO W.H.P.M, Inc. 5358 Irwindale Ave., Suite B Irwindale , CA 91706 United States johnwan@whpm.com
FEI Number: N/A
Country: United States
Issue Date: June 30, 2022
Issuing Office: Office of Medical Device and Radiological Health Division 3
Product Type: Other
Status: Closed
Closeout Letter: March 13, 2023

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.