FDA WARNING_LETTER - Professional World Store - February 26, 2021

The FDA issued a Warning Letter to Professional World Store on April 27, 2021, following a February 26, 2021 review of their website, www.professionalworldstore.com. The letter addresses the sale of "KN95 Specialised Face Mask," "3-Layer Disposable Surgical Masks," and "3 Layer Disposable Masks For Kids" in the U.S. The FDA determined these products are devices under section 201(h) of the Act. The firm is in violation for offering these devices without required marketing approval, clearance, or authorization. Consequently, the products are adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) due to the lack of an approved PMA or IDE. They are also misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) for failing to provide 510(k) premarket notification. Furthermore, the KN95 Specialised Face Mask and 3-Layer Disposable Surgical Masks are misbranded under section 502(a) of the Act (21 U.S.C. § 352(a)) because their labeling contains false or misleading representations, including unauthorized use of the FDA logo and false claims of FDA approval or certification. The FDA requires a written response within 15 business days detailing corrective actions, prevention plans, and a timetable for implementation, emphasizing the need to review all labeling and promotional materials for compliance.