FDA WARNING_LETTER - MTI Precision Products LLC. - April 30, 2014

An FDA inspection of MTI Precision Products LLC (MTI Dental Products) from April 17-30, 2014, revealed that their manufactured dental devices, including Lynx handpieces and Sonic Scalers, are adulterated. The firm's manufacturing methods, facilities, or controls do not conform with the Quality System (QS) regulation (21 CFR Part 820). The FDA identified ten significant QS regulation violations, including failures to establish and maintain adequate procedures for corrective and preventive action, design changes, complaint handling (both general and for Medical Device Reporting), purchasing controls, nonconforming product control, rework, device history records, quality audits, and personnel training. Additionally, the Lynx TM20 TorqueMaster low speed dental handpiece was found to be misbranded due to the firm's failure to report a device correction or removal to the FDA, as required by 21 CFR 806.10(a), following a recall initiated due to a sharp edge defect. MTI's response to the Form FDA 483 observations was deemed inadequate for all violations. The FDA requires prompt corrective action within fifteen working days, including documentation and a timetable for future corrections. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, and denial of premarket approvals or Certificates to Foreign Governments.