FDA 483 - Global Medical Production Co Ltd - July 30, 2021

An FDA inspection of Global Medical Production Co., Ltd. in Jiaxing, China, revealed numerous significant deficiencies in their quality system for medical devices exported to the US market. The firm lacked essential procedures for complaint handling, medical device reporting, design control, and device master records. Additionally, issues were identified with process validation, product identification, nonconforming product control, equipment maintenance, device history records, and personnel's understanding of US FDA regulations.