epro e-commerce limited – FDA Warning Letter, May 1, 2020
On June 30, 2020, the FDA issued a Warning Letter to the company operating the website dx.com, located in Hong Kong SAR, China. The letter states that on May 1, 2020, the FDA reviewed the website and observed the offering for sale of the "Wondfo Novel Coronavirus (2019-nCoV) Antibody Detection Kit" (aka "Antibody Detection Kit").
The FDA determined that this product is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 321(h), because it is intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19 in people.
The product was offered for sale and distributed in the United States without marketing approval, clearance, or authorization from FDA. This renders the product adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), as the firm lacks an approved application for premarket approval (PMA) or an approved investigational device exemption (IDE).
Furthermore, the product is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because
ID · 31d9938f-33c9-483d-9edb-43caf99466a9
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