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

During an FDA inspection conducted from May 22 to May 26, 2023, BYD Precision Manufacture Co., Ltd., a medical device manufacturer in Shenzhen, China, received a Form FDA 483 citing nine significant observations related to its quality management system. The inspection focused on the firm's compliance with regulatory frameworks governing medical devices, specifically 21 CFR Part 803 for Medical Device Reporting (MDR) and general quality system requirements for devices exported to the U.S. market.Key violations included the absence of established procedures for receiving, reviewing, and evaluating customer complaints, particularly from its U.S. customer support, to assess the need for investigation and MDR reporting. The company also lacked developed and implemented written Medical Device Reporting procedures. Furthermore, there was no documented objective evidence for process validation activities related to manufacturing Class II medical devices, such as N95 respirators and single-use surgical masks. Deficiencies extended to the absence of established procedures for design control, inadequate control of storage areas and finished device acceptance, and insufficient procedures for controlling environmental conditions and ensuring purchased products conform to specifications. Lastly, the Device Master Record for N95 and surgical masks was not adequately maintained, lacking critical specifications and procedures. The firm is responsible for implementing prompt corrective actions to address these observations and ensure full compliance with medical device regulations.