# FDA 483 - MTT GMBH - May 27, 2023

Source: https://www.keypedia.com/records/483/mtt-gmbh/30793b43-f722-4b7f-98d5-13e2ec1261c9

> FDA 483 for MTT GMBH on May 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MTT GMBH
- Inspection Date: 2023-05-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of MEDICAL TARGETING TECHNOLOGIES GMBH in Barum, Germany, identified significant deficiencies in their medical device quality system. The firm failed to maintain a device master record, establish procedures for device history records, and adequately define responsibilities for the disposition of nonconforming products. These observations indicate a need for improved quality system controls to ensure regulatory compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/mtt-gmbh/0a22ac13-78d8-43ec-94b6-655b7f70e821

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