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

Source: https://www.keypedia.com/records/483/philips-oral-healthcare-llc/99b8ff8a-751d-4196-9b58-53252898d09f

> FDA 483 for Philips Oral Healthcare, LLC on May 08, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Oral Healthcare, LLC
- Inspection Date: 2026-05-08
- Product Type: device
- Office Name: Seattle District Office
- Summary: 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.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/philips-oral-healthcare-llc/a4408f6d-1a7c-4cca-954a-e58e6767afaf

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913