FDA 483 - Lymol Medical Corporation - February 12, 2020

An FDA inspection of Lymol Medical Corporation in Woburn, MA, revealed significant deficiencies in its quality system for the Elite X Class Rigid Bronchoscope System. The firm failed to validate critical processes, adequately establish acceptance and design change procedures, and maintain essential device records. These issues indicate a broad breakdown in quality management practices, including repeat observations from previous inspections.