# FDA 483 - Philips Ultrasound, Inc - March 13, 2025

Source: https://www.keypedia.com/records/483/philips-ultrasound-inc/acd1170c-df40-4bb1-931a-2a22fd11a2ae

> FDA 483 for Philips Ultrasound, Inc on March 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philips Ultrasound, Inc
- Inspection Date: 2025-03-13
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Philips Ultrasound, Inc. in Reedsville, PA, revealed significant deficiencies across its quality management system. The firm failed to adequately establish corrective and preventive actions, maintain complaint files, control finished devices, and define supplier controls. These issues indicate a systemic breakdown in quality management practices, potentially impacting product safety and effectiveness.

## Related Officers

- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)
- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)

Company: https://www.keypedia.com/companies/philips-ultrasound-inc/878735c5-b993-485d-a94d-0b8a86561d37

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8