FDA 483 - Respironics, Inc. - February 14, 2023

Respironics, Inc. in Mount Pleasant, PA, was inspected by the FDA, resulting in one observation. The inspection found that the firm's remediation process for Trilogy 100 and 200 Ventilators, specifically the visual inspection of airpath assemblies for foam particulates, was not adequately validated. This lack of validation led to complaints of residual foam degradation particulates in reworked devices.