FDA 483 - Epic Systems Corporation - December 12, 2014

Epic Systems Corporation, a medical device firm in Verona, WI, was inspected by the FDA from December 1 to December 12, 2014. The inspection revealed issues primarily related to the firm's quality system, specifically concerning the maintenance of complaint files and the establishment of adequate procedures for management review and corrective and preventive actions. These observations indicate deficiencies in the firm's adherence to quality system regulations for medical devices.