Japan’s Mitaka Kohki Hit with 483 for Quality System Failures

Japan’s Mitaka Kohki failed to establish design control procedures, CAPA procedures, equipment calibration procedures, and documentation was found lacking for numerous critical processes during an inspection of the Tokyo-based facility.

The plant produces high-resolution microscopes used in surgery, and the firm had not established procedures for design control for its Point Setter models that were cleared under 510(k) notifications.

The firm had not established quality data sources to be analyzed to detect recurring quality problems, and no data analysis had been performed. No corrective and preventive actions had been initiated despite numerous complaints of movement of the Mitaka arm during surgery. — Tamra Sami