FDA WARNING_LETTER - Soleetech Corporation - May 15, 2013

An FDA inspection of Soleetech Corporation in Taipei, Taiwan, from May 13-15, 2013, revealed that the firm's airway (extension) connectors, classified as medical devices, were adulterated and misbranded. The devices were adulterated under section 501(h) of the Act due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820). Key QS violations included the absence of established procedures for corrective and preventive action (CAPA), control of nonconforming product, complaint handling, production process controls, document control, identification of valid statistical techniques, Device History Records (DHRs), and quality audits. Additionally, the devices were misbranded under section 502(t)(2) because the firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Soleetech Corporation must notify the FDA within fifteen business days of the specific steps taken to correct these violations, prevent recurrence, and provide a timetable for any ongoing corrective actions. Failure to address these systemic quality and regulatory deficiencies could impact federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments.