FDA WARNING_LETTER - Xanacare Technologies, LLC - August 04, 2014

The FDA inspected Xanacare Technologies, LLC from July 31 to August 4, 2014, regarding their SimulCare II device, a therapeutic lamp/nerve stimulator/massager. The inspection revealed the device is adulterated under section 501(h) of the Act due to non-conformity with current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Key QS violations include failures in design change procedures (21 CFR 820.30(i)), supplier evaluation (21 CFR 820.50(a)(1)), corrective and preventive actions (21 CFR 820.100), Device History Records (21 CFR 820.184), complaint handling (21 CFR 820.198(a)), incoming product acceptance (21 CFR 820.80(b)), finished device acceptance (21 CFR 820.80(d)), and quality audits (21 CFR 820.22). Additionally, the SimulCare II is adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) because major design changes were made without submitting a new 510(k) premarket notification, as required by 21 CFR 807.81(a)(3)(i). The FDA requires a written response within fifteen business days detailing corrective actions and prevention plans, warning of potential regulatory actions like seizure, injunction, and impact on future approvals or contracts if violations are not promptly corrected.