Narishige Design Control Procedures Faulted

FDA inspectors observed various problems at a Narishige medical device facility in Tokyo, including inadequate design control procedures and other violations.

After visiting the firm’s Toyko facility, inspectors cited the company because the design control procedures did not state that design changes would be validated or verified.

The design history file for one product did not include verification that the design output met the design input.

The design history file for a separate product included design inputs, but there was no documentation to verify that the design output matched the design input.

Read the Form 483 here: www.fdanews.com/02-17-17-narishigecoltd483.pdf.