FDA 483 - MD Instruments Mfg. Co., Ltd. - April 13, 2023

MD Instruments Mfg. Co., Ltd. in Inashiki-gun, Ibaraki, Japan, was inspected regarding its manufacturing of medical devices and electronic products. The inspection revealed significant deficiencies in establishing and maintaining records related to electronic product radiation safety tests for their diagnostic X-ray systems. These issues indicate a lack of proper documentation for test methods, devices, and procedures.