FDA 483 - The Yoshida Dental Manufacturing Co., Ltd. - April 14, 2023

The Yoshida Dental Manufacturing Co., Ltd. in Sumida-Ku, Tokyo, a medical device and electronic product manufacturer, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures and implementation for corrective and preventive actions, medical device reporting, design input, design output, and design validation. These issues indicate a systemic lack of control over critical aspects of device design and quality management.