FDA Flags Invacare for Inadequate Supplier Controls

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 agency found Invacare’s supplier controls procedure failed to define levels of control or quality requirements for affiliates, with the documentation stating the only affiliate requirement was being listed on the Approved Supplier List.

The supplier files were also insufficient, lacking required documentation such as completed supplier agreements, and procedures do not define how a supplier is moved from “approved” to “conditionally approved” or “restricted” status.