FDA EIR - Philips Respironics, Inc. - November 09, 2021

An FDA inspection of Philips Respironics, Inc.'s Murrysville, PA facility took place from August 26 to November 9, 2021. This comprehensive inspection served as a follow-up to two ongoing Class 1 medical device recalls, initiated due to the degradation of polyester polyurethane foam and emission of volatile organic compounds from various ventilator, CPAP, and BiPAP devices. Over 15 million units globally were affected by these recalls, which present risks such as irritation, inflammatory responses, and potential toxic effects from particle inhalation or chemical exposure. Conducted under the Compliance Program for Medical Device Manufacturers, the inspection identified several critical issues, resulting in an eight-item FDA Form 483. Key observations included: inadequate risk analysis, particularly concerning known foam degradation issues dating back to 2015-2016; deficiencies in establishing and implementing corrective and preventive action procedures; failures in design validation to ensure devices meet user needs; inadequate design change processes; and the firm's failure to report device corrections or removals to the FDA. Furthermore, the inspection highlighted management's executive responsibility not ensuring quality policy implementation, along with inadequate controls for purchased products and services, and insufficient evaluation of consultants. Philips Respironics is required to address these serious regulatory findings to ensure product safety and compliance.