ELYRIA, Ohio--(BUSINESS WIRE)--Invacare Corporation today announced that the U.S. Food and Drug Administration (FDA) has requested that the Company negotiate and agree to a consent decree of injunction relating to previously disclosed inspectional observations at the Companys corporate facility and its wheelchair manufacturing facility in Elyria, Ohio. The FDA has proposed a consent decree that would require suspension of certain operations at the facilities until they are determined by the FDA to be in compliance. Invacare has confirmed that it intends to enter into discussions with the FDA regarding the terms of the consent decree.
As the industry leader in the manufacture and distribution of innovative home and long-term care medical products, Invacare is committed to full compliance with FDA regulations, and it intends to work cooperatively with the FDA to resolve the agencys concerns. Over the past year, the Company has made systemic improvements in its FDA compliance processes. The Company also has added internal resources and engaged outside experts with proven medical device regulatory experience in order to accelerate these improvements.
Invacare Corporation, headquartered in Elyria, Ohio, is the global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles. The Company has 6,200 associates and markets its products in approximately 80 countries around the world. The Company was named to the 2011 Fortune 1000 list and to the 2010 IndustryWeek U.S. Manufacturing 500. For more information about the Company and its products, visit Invacare's website at www.invacare.com.
Posted by Sean Fenske, Editor-in-Chief, MDT