FDA WARNING_LETTER - Medical Positioning Inc. - January 11, 2011

This FDA Warning Letter, Ref: KAN 2011-07, was issued to Medical Positioning Inc. following an inspection from December 20, 2010, to January 11, 2011. The inspection revealed that the firm's radiographic tables and electrocardiograms are adulterated under section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). Additionally, devices were found to be misbranded under section 502(t)(2) due to failures related to Medical Device Reporting (MDR) (21 CFR Part 803) and Reports of Corrections and Removals (21 CFR Part 806). Significant QS regulation violations include inadequate procedures for corrective and preventive actions, purchasing controls, device history records (DHRs), device master records (DMRs), document control, design transfer, training, design validation, and design reviews. Misbranding issues involved failure to submit timely MDR reports for device malfunctions likely to cause serious injury, such as tables collapsing with patients, and failure to provide complete information for corrections/removals or justify unreported actions. The firm's response was deemed inadequate, lacking evidence of completed corrective actions and effective criteria. Medical Positioning Inc. must promptly correct these violations within fifteen business days, providing documentation and a timetable. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.