FDA WARNING_LETTER - Westminster International Ltd - February 25, 2021

The FDA issued a Warning Letter to Westminster House, Blacklocks Hill, Banbury, Oxfordshire, OX17 2BS, United Kingdom, on February 25, 2021, after reviewing their websites, https://www.wi-ltd.com/ and https://www.wg-plc.com/. The letter addresses the sale of "WG 520" and "WG 620" products, intended for human body temperature measurement, in the United States.

The FDA determined these products are devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 321(h), due to claims indicating their intent to mitigate, prevent, treat, diagnose, or cure COVID-19.

The products are deemed adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), as they lack premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the agency of intent to introduce them into interstate commerce as required by section 510(k) of the Act