FDAnews Device Daily Bulletin


Dec. 19, 2005

The Department of Justice will not appeal a recent district court's decision to dismiss the FDA's lawsuit against Utah Medical Products (UTMD) over alleged violations of good manufacturing practice (GMP) requirements.

The Justice Department legal counsel notified UTMD that the "government is not appealing the Utah Medical decision," the firm said. The announcement follows an October ruling by the U.S. District Court in Utah, which concluded UTMD was in compliance with the FDA's Quality System Regulation (QSR) despite the agency's argument to the contrary.

The FDA filed the lawsuit in August 2004, alleging that UTMD repeatedly ignored serious violations of the QSR at the facility. The agency had sought a permanent injunction on sales of UTMD products until the firm could demonstrate it had corrected the deviations.

The district court, however, disagreed with all of the FDA's allegations, and stated in its order: "It makes no sense for the court to order Utah Medical to do something they are already doing." After the October ruling, the FDA said the disagreement was over the roads that UTMD selected to satisfy GMP requirements. "FDA thinks they don't satisfy GMP; the court disagreed. We see no effect of this decision beyond the facts of this case," an FDA spokeswoman said.