FDA 483 - DeVilbiss Healthcare LLC - August 25, 2021

DeVilbiss Healthcare LLC in Somerset, PA, was cited for significant deficiencies in its quality system, particularly concerning complaint handling, medical device reporting (MDR), and design controls for its 525DS Oxygen Concentrator. The firm failed to adequately establish procedures for receiving and evaluating complaints, properly investigate complaints, and ensure timely MDR submissions. Additionally, design verification was found insufficient, and risk analyses did not accurately reflect product hazards.