FDA 483 - New Star Lasers, Inc. - March 20, 2017

New Star Lasers, Inc. in Roseville, CA, a device manufacturer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) system, including failures to adequately establish and implement CAPA procedures, define effectiveness criteria, conduct effectiveness checks, and properly document CAPA activities and results. These issues indicate a systemic problem with the firm's quality management system.