Resources for Food and Drug Administration (FDA)

FDA details defibrillator maker's violations

blog.seattlepi.nwsource.com

When Bothell-based Physio-Control Inc. suspended shipments of its LIFEPAK defibrillators in January 2007, the company cited vague issues with its quality-control systems.

"We found a number of things in our quality-control systems back in our plant in Redmond that concerned us and concerned the FDA," said a spokesman for Physio-Control parent Medtronic then (read that story here).

Court documents filed last week, however, offer more details.The FDA's injunction against Medtronic and Physio-Control cites 11 violations, reported by FDA inspectors during a 2006 visit.

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