FDA WARNING_LETTER - Andi International

On June 25, 2013, the FDA issued a Warning Letter to Andi International (ANDI) regarding the marketing of hyperbaric chamber accessories without proper clearance or approval. The FDA's Office of Compliance reviewed ANDI's website, andihq.com, and identified several products, including LP Breathing-Air Supply Compressors, Pure Air 5 Filtration System, Chamber Active Air Cooler/Dehumidifier, Oxygen Concentrators & Accessories, Oxygen Humidifier Kit, and Oxygen Pressure Amplifier, as hyperbaric chamber accessories.

These accessories are considered Class 2 devices, requiring 510(k) premarket clearance. ANDI's products are adulterated under section 501(f)(1)(B) of the Act because they lack an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to notify the FDA of intent to commercially distribute, as required by section 510(k).

Furthermore, ANDI failed to fulfill annual establishment registration and device listing requirements for fiscal year 2013, as mandated by section 510 of the Act. This renders all of ANDI's devices misbranded under section 502(o).

ANDI must take prompt action to correct these violations. Failure to do so may result in regulatory actions, including seizure, injunction,