FDA 483 - ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS) - July 20, 2016

An FDA inspection of Zhongshan A & J Medical Equipment Co., Ltd. (JBS), a medical device manufacturer in Zhongshan City, Guangdong, China, revealed significant deficiencies in their quality management system. The firm was cited for inadequate corrective and preventive action procedures, statistically invalid sampling plans for raw materials and finished devices, and poorly maintained device history records. These observations indicate a need for substantial improvements in their quality processes.