FDA 483 - Guangzhou Health & Health Medical Equipment Co., Ltd. - March 21, 2019

Guangzhou Health & Health Medical Equipment Co., Ltd., a medical device manufacturer in Guangzhou, China, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, a lack of established complaint handling processes, and the absence of written Medical Device Reporting procedures. These issues indicate a systemic failure to manage product quality and safety effectively.