Invacare (IVC) said in a regulatory filing late Monday that its wholly owned subsidiary, Alber GmbH, has received a warning letter from the U.S. Food and Drug Administration following an inspection of Alber’s facility in Albstadt, Germany in May 2017.

IVC shares were down 1.2% in the after hours session.

The warning letter requires completion of corrective actions to address the FDA Form 483 observations following the inspection.

As a consequence of the warning letter, Alber Twion Power Assist devices will not be imported into the United States until all findings are corrected to FDA’s satisfaction.

Although the company does not expect this action to have a significant impact on its financial results, it takes FDA’s observations very seriously and is working diligently to address these observations and respond to FDA’s warning letter in a timely manner.


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