FDA WARNING_LETTER - Robbins Instruments, LLC - May 31, 2024

On January 21, 2025, the FDA issued a Warning Letter to Robbins Instruments, LLC, following an inspection from March 27 to May 31, 2024, at their Houston, TX facility. The firm manufactures and distributes the Dermo-Jet Needleless Injector, which the FDA determined is an unapproved and misbranded device.

The Dermo-Jet Needleless Injector is marketed without FDA marketing clearance or approval, violating sections 501(f)(1)(B) and 502(o) of the Act. The device is adulterated because it lacks an approved premarket approval (PMA) or investigational device exemption (IDE), and misbranded due to failure to submit a 510(k) premarket notification. The instructions for use and product brochure outline numerous indications, including local anesthesia, vaccinations, mesotherapy, and treatments for various dermatological, urological, and gynecological conditions, none of which have FDA clearance.

The inspection also revealed significant Quality System regulation violations (21 CFR Part 820), indicating the devices are adulterated under section 501(h). Deficiencies include: 1. Failure to revalidate sterilization process changes (21 CFR 820.75(c)) and establish a process validation procedure (21 CFR 820.75(b)). 2. Failure to