Devices & Diagnostics

Facing FDA scrutiny, Invacare moving some wheelchair production to Mexico

Invacare (NYSE:IVC) plans to move production of a line of manual wheelchairs to Mexico from Ohio, as the home health products company is in the midst of negotiating a legal settlement with the FDA over issues with wheelchair production in the Elyria, Ohio, plant. The Cleveland-area company will shift production of its Solara line of […]

Invacare (NYSE:IVC) plans to move production of a line of manual wheelchairs to Mexico from Ohio, as the home health products company is in the midst of negotiating a legal settlement with the FDA over issues with wheelchair production in the Elyria, Ohio, plant.

The Cleveland-area company will shift production of its Solara line of manual wheelchairs to an existing plant in Reynosa, Mexico, but doesn’t plan any layoffs associated with the move, two local newspapers reported.

An Invacare spokeswoman didn’t immediately return a call.

The move is almost certainly a response to a proposed consent decree from the U.S. Food and Drug Administration. In December, Invacare announced that the FDA had asked it to enter into a legal agreement that would require the company to suspend “certain” wheelchair manufacturing operations at the Elyria plant.

At the time, CEO Gerry Blouch wouldn’t go into detail about any of the issues the FDA cited at the Elyria factory, saying only that the alleged violations “relate generally to processes” involved in the manufacture of wheelchairs.

Invacare said at the time that it was in negotiations with the FDA over the final structure of the agreement, called a “consent decree of injunction.” Those negotiations are apparently ongoing, though it’s unclear if moving the Solara line fulfills the FDA’s request of suspending “certain” manufacturing operations in Elyria.

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An Invacare spokeswoman told the Elyria Chronicle-Telegram that employees currently working on the Solara line would be switched to other products  manufactured in Elyria, including power and manual wheelchairs. The company already manufactures some manual wheelchairs at the Mexico location.