GE Healthcare Signs Consent Decree with FDA

The problems included failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions (CAPA). Under terms of the decree, the firm must hire an independent auditor to inspect the facilities and certify that the corrections have been made. It must also submit to annual inspections by an independent auditor for four years, and it must come up with a plan to bring the affected models already in use into compliance. The models cited were the 9900 Elite C-Arm System, 9900 Elite NAV C-Arm System, 9800 C-Arm System, 2800 UroView System, 6800 MiniView System, Insta-Trak 3500 NAV System, and ENTrak 2500 NAV System, as well as their components and accessories. GE has issued recalls for some of the models.Frankly, in this day and age, there is no excuse for a firm of this size to have a broken CAPA system. It is well known that CAPA is one of the most frequently targeted areas in FDA inspections. It is also well known that there are many CAPA solutions out there, and many consultants who know how to make them work. Why any firm with significant resources would risk having an inadequate CAPA system is unfathomable.