# FDA 483 - DOT Gmbh - November 16, 2023

Source: https://www.keypedia.com/records/483/dot-gmbh/c3039592-965b-4f77-a5a7-fdad16c1cc23

> FDA 483 for DOT Gmbh on November 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DOT Gmbh
- Inspection Date: 2023-11-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of DOT GmbH, a manufacturer in Rostock, Germany, revealed significant deficiencies in the firm's quality system. The inspection found that procedures for receiving, reviewing, and evaluating complaints and nonconformances were not adequately established. Specifically, the firm failed to provide sufficient documentation and details within nonconformance reports regarding effectiveness monitoring and root cause investigations.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/dot-gmbh/62752aff-58c0-4c00-9c6a-eea38530056b

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