FDA 483 - Ming Fai Industrial (Shenzhen) Co LTD - March 10, 2023

Ming Fai Industrial (Shenzhen) Co. Ltd. in Shenzhen, China, received six observations during an FDA inspection from March 6-10, 2023. The inspection revealed significant deficiencies in the firm's quality system procedures for medical devices intended for the U.S. market. Key issues included inadequate complaint handling, lack of Medical Device Reporting procedures, insufficient process validation documentation, and poorly established design control, storage area control, and finished device acceptance procedures.