FDA 483 - EZGO GROUP INC - December 22, 2021

An FDA inspection of EZGO GROUP INC, an initial importer of Class I and II medical devices in Rancho Cucamonga, CA, revealed significant deficiencies in their quality system. The firm failed to establish fundamental procedures for design control, corrective and preventive actions, complaint handling, and medical device reporting. These observations indicate a lack of basic quality system infrastructure for a medical device importer.