# FDA 483 - Siemens Medical Solutions USA, Inc. - January 06, 2023

Source: https://www.globalkeysolutions.net/records/483/siemens-medical-solutions-usa-inc/6fa6528a-38e9-4aa4-aa9e-c769792169dc

> FDA 483 for Siemens Medical Solutions USA, Inc. on January 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Siemens Medical Solutions USA, Inc.
- Inspection Date: 2023-01-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Siemens Medical Solutions USA, Inc. in Issaquah, WA, revealed significant deficiencies in their quality system for manufacturing diagnostic ultrasound systems. The firm failed to establish adequate procedures for corrective and preventive actions, design controls, and complaint handling. Additionally, their sampling plans for transducer testing lacked valid statistical rationale, indicating a need for improved regulatory compliance.

## Related Documents

- [483 - 2024-01-31](https://www.globalkeysolutions.net/records/483/siemens-medical-solutions-usa-inc/e1a64a29-9e2f-4ba9-abf7-926880f42880)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/siemens-medical-solutions-usa-inc/d1fd6cea-59f9-4236-8f53-b34f9294fde4

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