FDA 483 - DeVilbiss Healthcare LLC - August 17, 2022

DeVilbiss Healthcare LLC, a manufacturer of medical devices in Somerset, PA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for complaint handling, complaint investigation, design verification, and corrective and preventive actions, many of which were repeat observations. These issues primarily concerned premature cup seal failures in oxygen concentrators and inadequate design verification for environmental conditions and temperature limits.