FDA WARNING_LETTER - Sethi Laboratories - March 19, 2021

On April 6, 2021, the FDA issued a Warning Letter to Sethi Laboratories following a review of their websites on March 19, 2021. The FDA observed the sale of "Rapid COVID-19 Antibody Self Test Kit" and "Rapid COVID-19 Antigen Self Test Kit," marketed for self-testing at home or outside healthcare settings.

These products are classified as devices under the Federal Food, Drug, and Cosmetic Act (the "Act") due to their intended use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The FDA found the products to be adulterated under section 501(f)(1)(B) of the Act because Sethi Laboratories lacked approved applications for premarket approval (PMA) or investigational device exemptions (IDE).

Furthermore, the products were deemed misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k). The company also misbranded products under section 502(a) by falsely claiming "FDA Emergency Use Authorized" status and using the FDA logo, which is reserved for official use.

The FDA emphasized that current Emergency Use Authorizations for the underlying tests (Healgen Scientific LLC’s COVID-19 IgG/IgM Rapid Test Cassette and Access Bio, Inc.’s