FDA 483 - Jiangsu Caina Medical Co., Ltd - March 23, 2024

The FDA inspection of JIANGSU CAINA MEDICAL CO., LTD in Jiangyin, China, revealed significant quality system deficiencies for medical devices intended for the US market. The firm failed to submit required MDR reports, lacked adequate corrective and preventive action procedures, and had insufficient risk analysis. Additionally, issues included poor control of nonconforming products, improper identification of product acceptance status, and inadequate device history records, compounded by personnel unfamiliar with US FDA regulations.