FDA WARNING_LETTER - Fast Masks USA LLC - March 22, 2021

On March 26, 2021, the FDA issued a Warning Letter to Fast Masks USA, LLC, following reviews of their websites (www.fastmasksusa.com and www.FastMedicalUSA.com) on December 1, 2020, March 11, 2021, and March 22, 2021. The FDA found that Fast Masks USA, LLC was offering and distributing "At-Home COVID-19 Test Kit," "COVID Test Kit (25 Tests)," "COVID-19 Antibodies Test Kit," "SKY Medical Supplies & Equipments, LLC Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 RAPID TEST DEVICE Whole Blood/Serum/Plasma," and "Xiamen Wiz Biotech CO., LTD SARS-CoV-2 Antigen Rapid Test Test Device" (collectively, "COVID-19 Test Kits").

These products are classified as devices under section 201(h) of the Act, 21 U.S.C. § 321(h), as they are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The FDA determined these products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(