FDA 483 - Won Industry Co. LTD - April 11, 2019

Won Industry Co. LTD, a medical device manufacturer in Siheung-si, Korea, was cited with five observations during an FDA inspection from April 8-11, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, design validation, medical device reporting, complaint handling, and device history records. These issues indicate a systemic lack of established and followed quality management processes.