LSI Solutions, Inc. – FDA 483, Oct 4, 2018

An FDA inspection of LSI Solutions, Inc. in Victor, NY, a medical device manufacturer, revealed significant deficiencies in their corrective and preventive action (CAPA) system. The firm failed to adequately document CAPA activities and results, and their CAPA procedures were not fully established to describe necessary documentation requirements. These issues indicate a lack of robust quality system controls.