# FDA 483 - Siemens Medical Solutions USA, Inc - October 26, 2022

Source: https://www.globalkeysolutions.net/records/483/siemens-medical-solutions-usa-inc/62a02ffc-69ba-46dd-950d-721adaa82ed7

> FDA 483 for Siemens Medical Solutions USA, Inc on October 26, 2022. 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: 2022-10-26
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Siemens Medical Solutions USA, Inc. in Malvern, PA, revealed significant deficiencies in the installation and documentation processes for their angiographic X-ray systems. The firm failed to properly document installation inspections and test results, lacked calibration documentation for testing equipment, and had incomplete assembly installation records. These issues indicate a breakdown in the firm's quality system regarding medical device installation and associated record-keeping.

## Related Officers

- [Investigations](https://www.globalkeysolutions.net/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.globalkeysolutions.net/companies/siemens-medical-solutions-usa-inc/6edd49f1-05c5-4343-a2b7-4008bb315702

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