# FDA 483 - DFS Diamon GmbH - September 20, 2019

Source: https://www.keypedia.com/records/483/dfs-diamon-gmbh/064e1ec7-df48-4725-a249-c15785783ba7

> FDA 483 for DFS Diamon GmbH on September 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DFS Diamon GmbH
- Inspection Date: 2019-09-20
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: DFS Diamon GmbH, a medical device manufacturer in Riedenburg, Germany, was inspected by the FDA. The inspection revealed significant deficiencies in supplier management, including the use of unapproved suppliers and inadequate procedures for purchased products. Additionally, the firm failed to maintain complete device history records for its medical devices.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/dfs-diamon-gmbh/02748a3f-0960-4b2b-b9d8-3d45dc19bb6a

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