# FDA 483 - Philips North America LLC - October 27, 2022

Source: https://www.keypedia.com/records/483/philips-north-america-llc/07765b62-95e0-48d2-8ad6-d8323c1a8c63

> FDA 483 for Philips North America LLC on October 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips North America LLC
- Inspection Date: 2022-10-27
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Philips North America LLC in Bothell, WA, revealed significant deficiencies in their quality system. The firm failed to timely submit Medical Device Reports for device malfunctions and lacked an effective system for identifying and evaluating reportable events. Additionally, procedures for corrective and preventive actions were found to be inadequately established, leading to missed deadlines and incomplete investigations.

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## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.keypedia.com/companies/philips-north-america-llc/d7335702-bc34-4fb8-acdc-db91e81d2f8c

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