FDA WARNING_LETTER - Iradimed Corporation - April 16, 2014

An FDA inspection of Iradimed Corporation in Winter Park, Florida, from April 7-16, 2014, revealed that the firm's MRI infusion pumps, IV lines, and infusion stands are adulterated under section 501(h) of the Act, as their manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). Key violations include failures to establish and maintain procedures for device design validation (21 CFR 820.30(g)), documenting design review results (21 CFR 820.30(e)), identifying training needs (21 CFR 820.25(b)), and implementing effective corrective and preventive actions (CAPA) (21 CFR 820.100(a)). The firm's responses to some observations were deemed inadequate or required further verification. Additionally, the Mridium 3860 and 3850 MRI infusion pumps were found to be adulterated and misbranded due to significant software modifications without new 510(k) clearance (21 CFR 807.81(a)(3)(1)). The Mridium 3860+ infusion pump was also adulterated and misbranded for being marketed without any prior clearance or approval. Iradimed Corporation is required to immediately cease commercial distribution of these non-compliant devices and take prompt, comprehensive corrective actions, including addressing systemic problems, within fifteen business days. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts and device approvals.