The FDA faulted Invacare on its supplier controls and quality documentation.
The agency issued the devicemaker a Form 483 following a May/June inspection of its Elyria, Ohio, facility. The inspector found Invacare’s supplier controls failed to define levels of control or quality requirements for affiliates, with the documentation stating the only affiliate requirement was to be listed on the approved supplier list.
The supplier files were also insufficient, lacking required documentation such as completed supplier agreements, and procedures did not define how a supplier is moved from “approved” to “conditionally approved” or “restricted” status.
Investigators also found the company’s motor supplier was listed on “restricted” approval status since 2012 and was using a protocol that expired in 2013.