FDA 483 - Jiangsu Caina Medical Co., Ltd - July 18, 2025

An FDA inspection of Jiangsu Caina Medical Co., Ltd. in Jiangyin City, China, revealed significant deficiencies in their quality system. Observations included inadequate procedures for medical device reporting, corrective and preventive actions, process validation, and procurement control. These issues indicate a lack of robust quality management practices for medical device manufacturing.