Seodong Medical Co – FDA 483, May 3, 2018

An FDA inspection of Geodong Medical Co in Busan, Korea, from April 30 to May 3, 2018, revealed multiple significant deficiencies in its quality system. The firm failed to adequately document design inputs, establish acceptance criteria for validation, and conduct thorough risk analyses. Additionally, there were critical shortcomings in complaint handling, Medical Device Reporting (MDR) procedures, corrective and preventive actions, nonconforming product control, and labeling activities, indicating a broad lack of compliance with regulatory requirements.