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

Source: https://www.keypedia.com/records/warning_letter/fast-masks-usa-llc/260e535e-1b98-48a7-8108-a957827452ad

> FDA WARNING_LETTER for Fast Masks USA LLC on March 22, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Fast Masks USA LLC
- Inspection Date: 2021-03-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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)(

## Related Officers

- [Director](https://www.keypedia.com/people/timothy-t-stenzel/c53bdcbc-5f38-4c82-b8fc-181624201c10)

Company: https://www.keypedia.com/companies/fast-masks-usa-llc/2f752935-8fdb-4aa1-acd9-7f36c35dc4ed

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7