FDA WARNING_LETTER - Heraeus Kulzer GmbH - March 10, 2011

An FDA inspection of Heraeus Kulzer GmbH in Dormagen, Germany, from March 7-10, 2011, revealed significant violations concerning their dental impression materials, classified as medical devices. The firm's devices were deemed misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), due to a failure to provide information required by section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803, the Medical Device Reporting (MDR) regulation. Specifically, the firm failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Their existing procedure only covered incidents within the European Union, omitting U.S. reportable events. A subsequent response from the firm dated April 6, 2011, was found inadequate, as the revised MDR procedures still lacked internal systems for timely identification, communication, and evaluation of MDR-reportable events. Furthermore, the procedures failed to include a standardized review process for determining reporting criteria, ensuring timely transmission of complete reports, and meeting documentation and record-keeping requirements, all mandated by 21 CFR 803.17. Heraeus Kulzer GmbH must notify the FDA within 15 working days with specific corrective actions, preventative measures, and a timetable for implementation. Failure to address these issues could impact the firm's ability to secure U.S. federal contracts, and the FDA emphasized that this letter is not an exhaustive list of all violations.