FDA WARNING_LETTER - Block Scientific - February 05, 2021

On March 18, 2021, the FDA issued a Warning Letter to Block Scientific, Inc. after reviewing their website, www.blockscientificstore.com, on February 5, 2021. The FDA observed the sale of "QUIKPACII COVID-19 ANTIBODY TEST KIT" and "Long Island Biotech COVID-19 Antigen Rapid Test (Colloidal Gold)", which are marketed for COVID-19 mitigation, prevention, treatment, diagnosis, or cure. These products are classified as devices under section 201(h) of the Act. The products are adulterated under section 501(f)(1)(B) because the firm lacks approved premarket approval (PMA) or investigational device exemption (IDE) applications (sections 515(a), 520(g)). They are also misbranded under section 502(o) due to the firm's failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k). Consequently, the introduction of these products into interstate commerce is prohibited under section 301(a), and any act rendering them misbranded while held for sale after interstate shipment is prohibited under section 301(k). Block Scientific was instructed to immediately cease selling all unapproved, uncleared, and unauthorized COVID-19 products and to respond via email within 48 hours, detailing corrective actions and preventative measures. Failure to comply could lead to legal action, including seizure and injunction, and the firm's addition to FDA's public list of non-compliant entities.