FDA WARNING_LETTER - Lucomed Spa - September 22, 2011

During an FDA inspection of Lucomed S.p.a. in Carpi, Italy, from September 19-22, 2011, the firm, which manufactures plastic components for hemodialysis blood lines, was found to have misbranded devices. This misbranding, under section 502(t)(2) of the Act, stemmed from a failure to comply with Medical Device Reporting (MDR) requirements (21 CFR Part 803). Specifically, Lucomed failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. The firm's October 10, 2011, response was inadequate as the submitted MDR procedure did not detail Lucomed's process for communicating adverse events. Additionally, the inspection identified nonconformances with the Quality System regulation (21 CFR Part 820). These included a failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a)), for which the firm's response appeared adequate. Another deficiency was the failure to establish and maintain adequate procedures for identifying training needs and ensuring personnel are trained (21 CFR 820.25(b)); the adequacy of this response could not be determined due to untranslated Italian supporting documents. Lucomed must provide a written response within fifteen business days detailing corrective actions, preventative measures, and a timetable, including English translations for all documentation. The FDA emphasized that these violations might indicate systemic quality management issues and could impact federal contracts.