USA Medical, LLC – FDA Warning Letter, Mar 15, 2022

On August 3, 2022, the FDA issued a Warning Letter to USA Medical LLC following an inspection from February 28 to March 15, 2022. The inspection revealed that USA Medical LLC, a manufacturer and distributor, distributed SARS-CoV-2 Antigen Rapid Test kits (COVID-19 Tests) without FDA marketing approval, clearance, or authorization. These products are deemed adulterated under section 501(f)(1)(B) and misbranded under section 502(o) and 502(a) of the Federal Food, Drug, and Cosmetic Act, due to lack of premarket approval/investigational device exemption, failure to notify the agency of intent to introduce devices into commercial distribution, and misleading labeling claiming EUA authorization.

The inspection also found the COVID-19 Tests adulterated under section 501(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations include failure to establish procedures for acceptance activities (21 CFR § 820.80(a)), control of nonconforming product (21 CFR § 820.90(a)), control and distribution of finished devices (21 CFR § 820.160(a)), supplier evaluation (21 CFR § 820.50), corrective and preventative action (21