FDA WARNING_LETTER - CreativeStar Solutions - February 12, 2021

The FDA issued a Warning Letter to CSSINCO on March 5, 2021, following a website review on February 12, 2021. The letter addresses the sale of "Artemis TI-CS-T11 Thermal Scanner" and "Artemis Gateway" (Thermal Scanners) on https://cssinco.com/.

The FDA determined these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19, classifying them as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The products are deemed adulterated under section 501(f)(1)(B) because CSSINCO lacks approved premarket approval (PMA) or investigational device exemption (IDE) applications. They are also misbranded under section 502(o) for failure to notify the FDA of intent to introduce these products into interstate commerce as required by section 510(k).

The FDA highlights public health risks associated with telethermographic devices, including inaccurate temperature readings, which could lead to non-adherence to infection control guidelines. The company's website indicates the Thermal Scanners are intended for simultaneous scanning of multiple individuals.

CSSINCO is required to take immediate action to cease the sale of these adulterated and misbranded products for COVID-19 related uses. Within 48 hours, the company must email COVID