# FDA 483 - PSM Medical Solutions - July 24, 2019

Source: https://www.globalkeysolutions.net/records/483/psm-medical-solutions/b303c4a2-b201-40da-b84e-ecdbfdf1d195

> FDA 483 for PSM Medical Solutions on July 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PSM Medical Solutions
- Inspection Date: 2019-07-24
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection, PSM Medical Solutions, a medical device manufacturer in Gunningen, Germany, was cited for failing to establish procedures for design validation. This deficiency was specifically noted in the design of their PSM BENEfit/quattro Screws, indicating a significant lapse in their product development quality system. The firm's own procedure defined design validation, but the necessary procedures were not implemented.

## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/psm-medical-solutions/c74e7009-409d-43b4-accf-2c25119ea19b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd