# FDA 483 - Peramed Medizintechnik - July 25, 2019

Source: https://www.keypedia.com/records/483/peramed-medizintechnik/d85230f0-ec4e-4a1a-abb4-80c9083f533a

> FDA 483 for Peramed Medizintechnik on July 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Peramed Medizintechnik
- Inspection Date: 2019-07-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Femed Medizintechnik, a medical device manufacturer in Tuningen, Germany, was inspected by the FDA. The inspection revealed that the firm had not developed adequate production processes or established quality controls for the manufacturing of their PSM BENEfit/quattro screws, failing to ensure the device conforms to its specifications.

## Related Officers

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

Company: https://www.keypedia.com/companies/peramed-medizintechnik/462f1073-bc87-4133-b9dd-761fe0291b35

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