Roger William Worrall
Westminster International Ltd
Westminster House, Blacklocks Hill (Banbury Lane)
Banbury, Oxfordshire
OX17 2BS
United Kingdom
r.worrall@wg-plc.comIssued Mar 4, 2021Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateMar 4, 2021
Product TypeDrugs
StatusClosed
Closeout LetterMar 31, 2025
Letter Details
Firm
Westminster International Ltd
Location
Roger William Worrall
Westminster International Ltd
Westminster House, Blacklocks Hill (Banbury Lane)
Banbury, Oxfordshire
OX17 2BS
United Kingdom
r.worrall@wg-plc.com
FEI Number
N/A
Country
United Kingdom
Issue Date
March 04, 2021
Issuing Office
Center for Devices and Radiological Health
Product Type
Drugs
Status
Closed
Closeout Letter
March 31, 2025
Summary
Westminster International Ltd marketed thermal camera products (WG 520 and WG 620) as devices intended to screen for, detect, and diagnose COVID-19 and other infectious diseases without obtaining required FDA clearance or approval, making them adulterated and misbranded under federal law. The company's websites explicitly positioned these temperature-measurement devices as "Coronavirus Covid-19, Flu, Ebola Screening Systems" and stated they were "designed by medical professionals to be used as a first level mass screening test for identifying individuals that have an above normal body temperature and may be suffering from Coronavirus" and other pathogens. By making disease claims without proper regulatory authorization, the products violated the Federal Food, Drug, and Cosmetic Act's requirements for medical devices intended to diagnose, treat, prevent, or mitigate disease.
Westminster International Ltd FDA Warning Letter, March 4, 2021