Consent Decree for Medtronic Unit
April 28th, 2008 joshua
Medtronic and the Food and Drug Administration have an agreement over the company’s quality control issues at a subsidiary facility making external heart defibrillators.
FDA inspections at Physio-Control Inc., a wholly-owned subsidiary of Medtronic, revealed questionable practices of the company’s “quality system processes” in the manufacture of external defibrillators and regulators outlined actions Physio-Control could take to remediate the problems.
The agreement must be finalized and approved by a Washington state court.
In a statement, Physio-Control president Brian Webster says, “During the last year, we’ve made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution.”
Physio-Control was permitted to ship its external defibrillators to patients in need of critical care. This agreement with the FDA would allow the company to ship the defibrillators freely again.
