# FDA 483 - Wittenstein intens GmbH - March 11, 2019

Source: https://www.keypedia.com/records/483/wittenstein-intens-gmbh/26029b05-2f88-4af2-8ffa-d56034d7c1cd

> FDA 483 for Wittenstein intens GmbH on March 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wittenstein intens GmbH
- Inspection Date: 2019-03-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Wittenstein intens GmbH, a device manufacturer in Harthausen, Germany, revealed two significant observations. The firm failed to submit a Medical Device Report (MDR) within 30 days for a malfunctioning Fitbone device. Additionally, the validation of the laser welding process for the Fitbone device was found to be inadequate, with testing involving only two pieces and one failing to meet acceptance criteria.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/wittenstein-intens-gmbh/4465d81e-4663-45d4-ad47-da7a04b4f684

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