# FDA 483 - Philips North America LLC - November 06, 2024

Source: https://www.keypedia.com/records/483/philips-north-america-llc/26742aad-485a-434d-837e-5e310835d6d4

> FDA 483 for Philips North America LLC on November 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips North America LLC
- Inspection Date: 2024-11-06
- Product Type: device
- Office Name: Seattle District Office
- Summary: An FDA inspection of Philips North America LLC in Bothell, WA, revealed significant quality system deficiencies. The firm was cited for inadequate documentation of corrective and preventive action activities, particularly concerning risk assessments for late regulatory reporting and delayed complaint processing, which was a repeat observation. Additionally, device history records for HeartStart HS1 and FRx Defibrillators were found to be incomplete, lacking required labeling information.

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## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

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