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

This FDA Form 483, dated November 9, 2021, details observations made during an inspection of Philips Respironics, Inc., a medical device manufacturer located at 1001 Murry Ridge Ln, Murrysville, PA. The inspection was conducted from August 26, 2021, to November 9, 2021. The report was issued to Rodney D. Mell, Head of Quality.

The primary observation noted is inadequate risk analysis. Specifically, the firm lacks documented investigation, risk analysis, or design failure mode effect analysis to support its rationale for which polyester polyurethane foam-containing products were included or excluded from ongoing Class 1 medical device recalls. These recalls, publicly announced on June 14, 2021, concern various ventilator, CPAP, and BiPAP devices due to foam degradation and volatile organic compound emission. The provided justification document, "REQ 310 - Rationale for Concluding which Devices are Impacted by the Recall," does not sufficiently demonstrate why other devices containing polyester polyurethane foam should not also be included in the recalls. This indicates a deficiency in the firm's quality system regarding risk management and product safety assessments.