During a 2004 inspection it was found that x-ray and fluoroscopic systems and accessories manufactured by General Electric were not manufactured in conformance with Quality System and Good Manufacturing Practices. Violations included “Failure of management with executive responsibility to ensure requirements are effectively established and effectively maintained,” “failure to establish and maintain procedures for implementing corrective and preventive actions,” and “Failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test.”