FDA 483 - Byd Precision Manufacture Co., Ltd - May 26, 2023

An FDA inspection of BYD Precision Manufacture Co., Ltd. in Shenzhen, Guangdong, China, revealed numerous significant deficiencies in their quality system for manufacturing Class II medical devices, including N95 and single-use surgical masks. The firm lacked established procedures for critical areas such as complaint handling, medical device reporting, process validation, design control, storage, finished device acceptance, environmental control, and supplier management. Additionally, the device master record was not adequately maintained, indicating a broad failure to comply with regulatory requirements.