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.
Moreover, procedures for receiving, reviewing and evaluating complaints by a formally designated unit had not been adequately established. For example, the firm failed to document two complaints from hospitals that the point setters didn’t have holding power, which resulted in a recall of the Mitaka Point Setters in April 2009.
The agency also found fault with the firm’s purchasing controls and device history records and procedures. The 483 noted that the device history record didn’t demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
The firm did not respond to a request for comment. Read the Form 483 here: www.fdanews.com/08-05-16-Mitaka483.pdf. — Tamra Sami