Lepu Medical Technology -Beijing- Co., Ltd. – FDA Warning Letter, Aug 10, 2021

The FDA issued a Warning Letter to a firm in Beijing, China, on July 29, 2021, regarding the sale of unapproved and unauthorized COVID-19 Test Kits in the United States. The products, including a Neutralization Antibody Test kit, a SARS-CoV-2 Antigen Rapid Test Kit, and a Saliva Antigen Rapid Test, are considered devices under the Federal Food, Drug, and Cosmetic Act due to their intended use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

The COVID-19 Test Kits are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks approved premarket approval (PMA) applications or investigational device exemptions (IDE). They are also misbranded under section 502(o) because the firm failed to notify the FDA of its intent to introduce the devices into commercial distribution, as required by section 510(k). The introduction or delivery of these products into interstate commerce is prohibited under section 301(a) and 301(k).

The FDA requests immediate action to cease the sale of these unapproved products. The firm must respond within 48 hours via email to COVID-19-Task-Force-CDRH@fda.hhs.gov, detailing specific corrective steps, preventative measures, and supporting documentation. Failure to comply may result in legal action