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TMJ executives liable for $630,000 in penalties

This article was originally published in The Silver Sheet

Executive Summary

Colorado-based TMJ Implants and two executives are liable for civil money penalties of up to $630,000 for not filing 17 adverse event reports, an FDA administrative law judge ruled July 6. The agency claims the dental implant maker did not submit the reports even after being advised of the need to do so in a 2004 warning letter. The company maintains its internal assessment showed the events did not meet the reporting threshold of causing or contributing to a serious injury, and appealed the matter to the FDA commissioner before the agency entered a complaint with the administrative court in July 2005
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