Philips, DOJ Reach Deal Over Defibrillator Missteps

Law360, New York (October 11, 2017, 8:19 PM EDT) -- Royal Philips’ North American unit has agreed to stop making external defibrillators at two facilities in Washington and Massachusetts until the U.S. Food and Drug Administration confirms that the locations comply with good manufacturing practices, the company said Wednesday.

The FDA and the U.S. Department of Justice sued Philips North America LLC and certain executives in Massachusetts federal court on Wednesday, seeking a permanent injunction that would stop Philips from making and distributing medical devices in facilities that violated manufacturing regulations. The government cited repeated warnings...
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