Philips Oral Healthcare, LLC – FDA 483, May 8, 2026

Philips Oral Healthcare, LLC, a specification developer in Bothell, WA, was cited for multiple significant quality system deficiencies during an FDA inspection. The observations primarily concern inadequate medical device reporting, insufficient risk management and design validation for thermal hazards, and failures in supplier monitoring and timely complaint handling. These issues indicate a lack of robust controls over product safety and quality processes.