FDA WARNING_LETTER - Rubimed AG - January 29, 2013

An FDA inspection of Rubimed AG in Hergiswil, Switzerland, from January 28-29, 2013, revealed that their REBA biofeedback device is adulterated and misbranded. The device is adulterated under section 501(h) of the Act for non-conformity with Quality System (QS) regulation (21 CFR Part 820) and under section 501(f)(1)(B) for lacking premarket approval (PMA) or an investigational device exemption. It is also misbranded under section 502(t)(2) for failing to furnish required information (MDR) and under section 502(o) for not submitting a 510(k) premarket notification. Key QS violations include failures to establish and maintain procedures for design control, corrective and preventive actions, complaint handling, complaint investigation records, purchasing controls, production processes, record maintenance, device history records, and quality audits. Additionally, the firm failed to implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). Rubimed AG's February 4, 2013, response was deemed inadequate as it lacked evidence of implementation, revised procedures, and training records. The FDA requires a written response within fifteen business days detailing specific corrections, preventive actions, and a timetable for completion. Failure to comply will result in continued refusal of admission for devices into the U.S. (detention without physical examination) and may impact federal contracts, PMA approvals, and Certificates to Foreign Governments.