FDA WARNING_LETTER - Omega Engineering Inc. - February 19, 2021

On February 19, 2021, the FDA reviewed Omega Engineering Inc.'s website and social media, identifying the "TI-120GTS" product offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. This establishes the product as a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. The FDA found the product to be adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). Furthermore, the product is misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) due to the firm's failure to notify the agency of its intent to introduce the product into interstate commerce, as required by section 510(k). Consequently, the introduction of this product into interstate commerce is prohibited under section 301(a) of the Act. The FDA emphasized the public health risks associated with unapproved telethermographic devices, especially those used for simultaneous group screening. Omega Engineering Inc. is required to immediately cease the sale of these adulterated and misbranded products. Within 48 hours, the firm must email the FDA, detailing corrective actions taken, steps to prevent recurrence, and supporting documentation, referencing CMS # 613560. Failure to comply may lead to legal action, including seizure and injunction, and the firm will be added to a public FDA list of companies selling fraudulent COVID-19 products.