FDA 483 - Intersect ENT, Inc. - November 03, 2017

An FDA inspection of Intersect ENT, Inc. in Menlo Park, CA, a sterile finished drug-device combination product manufacturer, revealed significant deficiencies. Observations included inadequate validation of manufacturing processes and computer systems, incomplete batch production records, and insufficient employee training for visual inspections. These issues indicate a lack of robust quality control and compliance with regulatory requirements.