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

An FDA inspection of Philips Oral Healthcare, LLC in Bothell, WA, revealed significant deficiencies across multiple quality system areas, primarily related to their Power Toothbrush and Battery Toothbrush devices. The firm failed to adequately report medical device malfunctions, document risk management processes, perform design verification and validation for thermal safety, and properly manage supplier performance and complaint handling. These issues indicate a systemic breakdown in ensuring product safety and regulatory compliance.