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# Inspectors Find Invacare Not Meeting Decree Terms
- URL: https://www.fdaweb.com/inspectors-find-invacare-not-meeting-decree-terms/
- Published: 2016-01-26T12:00:00.000Z
- Updated: 2026-09-15T02:30:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134562

> A five-month inspection at Invacare, Elyria, OH, found that the company is not living up to terms of a consent decree for its wheelchair manufacturing operations signed with FDA in 2013, a *Crain’s Cleveland Business* [report](http://www.crainscleveland.com/article/20160124/NEWS/160129921/fda-identifies-more-problems-at-invacare-corp?ref=fdaweb.com) says. An FDA-483 listed the inspection period as 7/16/15 to 12/9/15\. Inspection observations in the 483 included:  
> deviation from the procedural requirements of a decree of injunction by not implementing specific decree protocols; inadequate design control risk analysis; design verification does not confirm that design output meets design input requirements; design validation did not ensure that the device conforms to defined user needs and intended uses;· design input requirements were not adequately documented; inadequate documentation of monitoring and control methods and data for a validated process; and inadequate documentation of process validation activities.  
>  
> The injunction [decree](http://www.fdaweb.com/login.php?sa=v&aid=D5123798&searchWords=invacare&cate=S&stid=%241%24nX4.ka4.%24BeP69Fx3Fc11R.9eJ.EfV.) required the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and their components. At the time, FDA said that seven inspections since 2002 documented violations of Quality System regulations and failing to properly report adverse events to the agency.