FDA WARNING_LETTER - Sallamander Concepts CC Pty Ltd

The FDA issued a Warning Letter to Sallamander Concepts CC Pty Ltd for illegally marketing Sanitoets' Malaria home test, Urine test strips, and Prostate test in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. These products are classified as devices under section 201(h) of the Act. The devices were found to be adulterated under section 501(f)(1)(B) due to the absence of an approved premarket approval (PMA) application (section 515(a)) or an investigational device exemption (IDE) (section 520(g)). Additionally, the devices are misbranded under section 502(o) because the firm failed to provide required 510(k) premarket notification, did not register its establishment under section 510, and did not include the devices in a list required by section 510(j). Consequently, these devices are subject to refusal of admission into the U.S. under section 801(a). The firm must respond within fifteen working days, detailing specific corrective actions, prevention plans, and a timetable. Failure to address these violations will impact future PMA approvals, the granting of Certificates to Foreign Governments, and may affect U.S. federal contracts. The letter emphasizes the firm's responsibility to ensure overall compliance and investigate the root causes of these serious quality system issues.