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Robbins Instruments, LLC manufactured and distributed the Dermo-Jet Needleless Injector without obtaining required FDA marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The company failed to submit a premarket approval application (PMA) or investigational device exemption, making the device adulterated, and did not notify FDA of its intent to introduce the device through a 510(k) submission, rendering it misbranded. An FDA inspection conducted from March through May 2024 at the company's Houston, Texas facility identified these violations during routine compliance investigation.