# FDA 483 - Philips North America LLC - November 21, 2025

Source: https://www.keypedia.com/records/483/philips-north-america-llc/9bf2d49a-50ce-470b-89b0-67ad744f3fd3

> FDA 483 for Philips North America LLC on November 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips North America LLC
- Inspection Date: 2025-11-21
- Product Type: device
- Office Name: Seattle District Office
- Summary: An FDA inspection of Philips North America LLC in Bothell, WA, revealed significant deficiencies in the firm's complaint handling procedures for medical devices. The company failed to uniformly and timely process complaints, with issues identified in documentation, audit trails, and monitoring modifications to complaint records. Management was unable to provide adequate justification for these systemic problems.

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## 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-north-america-llc/d7335702-bc34-4fb8-acdc-db91e81d2f8c

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