FDA WARNING_LETTER - Baltimore Beauty Security Square Mall - May 12, 2021

On May 4, 2021, the FDA issued a Warning Letter regarding the sale of GenBody COVID-19 Ag and GenBody COVID-19 IgM/IgG tests ("COVID-19 Test Kits") in the United States. The FDA determined these kits are devices under section 201(h) of the Act, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The products are deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) of the Act for failing to notify the FDA of 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) of the Act.

The FDA requests immediate cessation of sales for these unapproved, uncleared, and unauthorized COVID-19 products. The firm must respond within 48 hours via email to [email protected], detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to the