Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Accordingly, your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
Passage 2Your products are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce these products into interstate commerce for commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
Passage 3“The T-Series can be used as a prevention solution for COVID-19” [Published on an undated blog post on your website, https://cssinco.com/blog/our-blog-1/post/artemis-t-series-thermal-scanners-31]
Passage 4“The Artemis Gateway is a leading solution in COVID-19 prevention.” [Published on your website, https://www.cssinco.com/artemis-gateway]
Passage 5“Scan up to 10 persons at a time for rapid screening” [Published on your “Artemis Thermal Scanner” webpage under the subheading “TI-CS-11”, https://cssinco.com/artemis-thermalscanner]
Passage 6“This model can scan up to 10 individuals at a single time.” [Published on your TI-CS-11 webpage, https://cssinco.com/ti-cs-t11-detail]