FDA 483 - Philips Respironics, Inc. - November 09, 2021

Philips Respironics, Inc. underwent an FDA inspection from August 26, 2021, to November 9, 2021, at its Murrysville, PA facility. The inspection was prompted by a voluntary recall of certain ventilator, CPAP, and BiPAP devices due to issues with the polyester-based polyurethane (PE-PUR) sound abatement foam, which could degrade and release harmful chemicals. The company had initially reported these issues to the FDA on May 7, 2021.

The FDA's inspection resulted in a Form 483, highlighting several compliance issues. In response, Philips Respironics is addressing these through a Corrective and Preventive Action (CAPA) process and implementing broader changes to enhance compliance with FDA regulations. This includes personnel changes, such as appointing David Ferguson as the new Business Leader and Thomas J. Fallon as the Head of Quality, both bringing extensive industry experience.

Philips Respironics has submitted multiple 510(k) premarket notifications to replace the problematic foam and developed rework protocols for affected devices. The company is actively coordinating with the FDA, providing detailed responses to inquiries, and participating in regular meetings to ensure effective remediation.

To strengthen its quality management system, Philips Respironics has expanded its team with experts in biocompatibility, cleaning, disinfection, and toxicology, and is investing in additional resources to support quality, regulatory, and post-market functions. These efforts aim to address the FDA's observations and prevent future compliance issues.