Physio-Control said Monday it agreed with the U.S. Food and Drug Administration on a plan to revamp its manufacturing quality-control procedures...
Physio-Control said Monday 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 in Seattle on Friday. If approved by the court, it will set a course for the Redmond medical-equipment maker to resume shipments of its external defibrillators.
Physio-Control expects to comply with the terms of the consent decree within its current fiscal quarter, which ends in July, or shortly after, said spokeswoman Anne Devine. It can begin shipments once its final report on the changes gets a nod from the FDA.
“We already completed a lot of the things [regulators] were concerned about,” Devine said.
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The agreement mandates that the company hire an independent expert to evaluate Physio-Control’s procedures once a year. A third-party audit was recently completed, and there’s “no requirement for one in the near future,” Devine said.
The company voluntarily suspended the U.S. distribution of its products in January 2007, 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, and led to layoffs.
Physio-Control continued to ship defibrillators to foreign markets, which accounted for about 40 percent of its pre-suspension revenue. But the accord forces it to restrict those sales as well until it fully complies with the FDA requests.
“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 Physio-Control President Brian Webster. “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 competes with a Seattle-based unit of Philips for the top position in the external-defibrillator market. The devices can jolt a failing heart back into action with an electrical charge.
Ángel González: 206-515-5644 or email@example.com