FDA 483 - SMC - December 11, 2025

SMC, a medical device manufacturer in Gimpo-si, Gyeonggi-do, Korea, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in corrective and preventive action procedures, lack of written Medical Device Reporting procedures, and inadequate supplier change notification agreements. These issues indicate a need for comprehensive improvements in the firm's quality management.