During a 2004 inspection it was found that a device produced by EDS was not being manufactured in conformance with Current Good Manufacturing Practice. Some Quality System (QS) violations included: failure “to ensure that the procedures for implementing corrective and preventive actions were complete,” that “software used by your firm as part of the quality system has not been fully validated for its intended use according to an established protocol,” and failure “to address design input requirements that are incomplete.” The Food and Drug Administration requested that EDS immediately take prompt action to correct these violations.