FDA 483 - Zhejiang Kindly Medical Devices Co., Ltd. - April 22, 2004

During an inspection from April 19-22, 2004, the FDA observed significant issues at Zhejiang Kindly Medical Devices Co., Ltd. in Wenzhou, China. The firm failed to define procedures to prevent contamination, specifically evidenced by rodent traps with food bait found in areas storing sterile finished goods and raw materials. This indicates a serious lapse in contamination control that could impact product sterility and quality.