FDA WARNING_LETTER - Lusys Laboratories, Inc. - September 24, 2021

On February 17, 2022, the FDA issued a Warning Letter to Lusys Laboratories, Inc. following an inspection from September 13-24, 2021, at their San Diego facility. The inspection revealed that Lusys Laboratories, Inc. manufactures and distributes COVID-19 IgG/IgM Antibody Test and COVID-19 Viral Antigen Test kits in the United States.

The FDA determined these COVID-19 Test Kits are medical devices intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The products were found to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because they were distributed without required marketing approval, clearance, or authorization (PMA or IDE). They were also deemed misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

The introduction or delivery of these products into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S