Physio-Control said today it agreed with the U.S. Food and Drug Administration on a plan to revamp its manufacturing quality-control procedures...
Physio-Control said today it agreed with the U.S. Food and Drug Administration on a plan to revamp its manufacturing quality-control procedures to comply with federal regulations.
The agreement was filed with the U.S. District Court for the Western District of Washington on Friday. If approved by the court, it will set a course for the Redmond-based medical equipment maker to resume shipments of its external defibrillators.
The agreement also mandates that the company hire an independent expert to evaluate Physio-Control’s progress in meeting the agency’s requirements.
The company voluntarily suspended the distribution of its products in the U.S. in January last year, supplying only critical clients, after the FDA found shortcomings in its quality-control procedures. The suspension prompted a delay in a planned spinoff of the company from its corporate parent, Medtronic.
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“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,” said Brian Webster, president of Physio-Control. “We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations.”
Physio-Control, along with a Seattle-based unit of Philips, is the largest manufacturer of external defibrillators. The devices can jolt a failing heart back into action with an electrical charge.
Ángel González: 206-515-5644 or email@example.com