FDA Proposes Work Suspension at Invacare

Agency says ‘violations’ led to consent decree that would suspend certain operations, Invacare says will discuss terms.

The Food and Drug Administration has proposed a consent decree that would require a suspension of work for major HME manufacturer Invacare Corp., saying the proposal was based on violations found during inspections of the Elyria, Ohio-based company’s corporate facility and its wheelchair manufacturing facility.

The FDA proposed the consent decree last Thursday, which would entail the suspension of certain operations at the facilities, and said that operations would not resume until the FDA concludes Invacare is in compliance with the FDA’s regulations.

Invacare has said that it intends to enter into discussions with the FDA regarding the terms of the consent decree.

On the heels of the FDA announcement, law firm Kahn Swick & Foti, LLC and its partner former Attorney General of Louisiana, Charles Foti, Jr. have commenced an investigation into Invacare. KSF is a law firm focused on securities class action and shareholder derivative litigation.

Subsequent to the FDA announcement, publicly traded Invacare’s stock (IVC) dropped 29 percent to $14.70 at the close of trading on Dec. 8, its biggest single-day decline since Dec. 27, 1984. Since then, the stock has been hovering between $15 and $16.

About the Author

David Kopf is the Editor of HME Business.

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