Respironics, Inc. – FDA EIR, Feb 14, 2023

An FDA inspection of Respironics, Inc. in Mount Pleasant, PA, was conducted from January 25 to February 14, 2023. This inspection was a follow-up to ongoing Class 1 recalls involving Philips Respironics ventilator, CPAP, and BiPAP devices due to foam degradation. The facility serves as a repackager, relabeler, warehouse, distribution, and service center, responsible for remediating Trilogy 100 & 200 ventilators. The primary violation cited on an FDA Form 483 concerned the lack of validation for the Trilogy 100/200 foam remediation process, specifically that the visual inspection method for detecting residual polyester polyurethane (PE-PUR) foam particles in airpath assemblies was deemed insufficient and not properly validated, despite complaints of residual foam post-remediation. Further issues included reports of replacement silicone foam delaminating in reworked Trilogy devices. For Dreamstation devices, which are remediated elsewhere and distributed from this facility, the inspection identified that patients were unable to connect to software due to inadvertent serial number entry errors during rework. Although the firm resolved the software issue, patient notification was significantly delayed. The inspection also highlighted systemic concerns regarding the company's Design Controls and Corrective and Preventive Action (CAPA) subsystems, noting CAPAs were often initiated late and root causes determined post-remediation, potentially leading to retroactive adjustments rather than proactive quality control. Respironics, Inc. management stated they would "consider" the observation, and the inspection was classified as Official Action Indicated (OAI).