This article was originally published in The Gray Sheet
FDA administrative law judge rules July 6 that 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. The events were documented in a February 2004 warning letter to the firm, which makes temporomandibular joint prostheses. 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 (1"The Gray Sheet" Jan. 1, 2007, p. 4). The case has resulted in pressure on FDA from House Republicans questioning the fairness of the warning letter appeals process based on TMJ's assertions that its plea to the commissioner was short circuited (2"The Gray Sheet" May 7, 2007, p. 7)...
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