# FDA 483 - Philips Oral Healthcare Inc - May 08, 2026

Source: https://www.keypedia.com/records/483/philips-oral-healthcare-inc/cead0748-7da7-4ac0-8826-a8a95a83c4c3

> FDA 483 for Philips Oral Healthcare Inc 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 Inc
- Inspection Date: 2026-05-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## 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-inc/a4408f6d-1a7c-4cca-954a-e58e6767afaf

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822