Wheelchair Maker Announces Layoffs In Wake of FDA Consent Decree

January 4, 2013
Invacare is laying off 143 employees as the company attempts to comply with an FDA consent decree that ended wheelchair manufacturing operations at two Elyria, Ohio, facilities, the company announced Dec. 27. The Dec. 19 consent decree, which requires Invacare to cease making and distributing manual and power chairs until multiple GMP violations are corrected, comes as no surprise. The devicemaker warned investors a year ago that the FDA had proposed a consent decree after a six-observation Form 483 could not be resolved.
The GMP Letter