# FDA 483 - Philips Ultrasound, Inc. - January 31, 2025

Source: https://www.globalkeysolutions.net/records/483/philips-ultrasound-inc/0bf17fee-3ec3-48b9-9b1f-9ca5f7baf873

> FDA 483 for Philips Ultrasound, Inc. on January 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Ultrasound, Inc.
- Inspection Date: 2025-01-31
- Product Type: device
- Office Name: Seattle District Office
- Summary: Philips Ultrasound, LLC received a Form 483 citing significant deficiencies in its quality system. The firm failed to adequately review and investigate complaints, particularly those related to MDR reportable events, and maintained incomplete complaint files. Additionally, the company's corrective and preventive action procedures were not effectively established or implemented, and there were critical gaps in supplier quality management for outsourced complaint handling and medical device reporting.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.globalkeysolutions.net/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)
- [Katelyn A. Staub-Zamperini](https://www.globalkeysolutions.net/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.globalkeysolutions.net/companies/philips-ultrasound-inc/36d048c6-d991-443c-b562-f9d7bacc8be8

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