# FDA 483 - DRG Instruments GmbH - November 07, 2024

Source: https://www.keypedia.com/records/483/drg-instruments-gmbh/72cbc096-84cf-4a84-8de1-888913b27b0c

> FDA 483 for DRG Instruments GmbH on November 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DRG Instruments GmbH
- Inspection Date: 2024-11-07
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of DRG Instruments GmbH, a medical device manufacturer in Marburg, Germany, revealed significant deficiencies in their quality system. Observations included inadequate corrective and preventive action procedures, undeveloped Medical Device Reporting (MDR) procedures, and incomplete complaint records. Additionally, the firm failed to provide required Unique Device Identifier (UDI) information to the Global UDI Database.

## Related Documents

- [WARNING_LETTER - 2016-10-28](https://www.keypedia.com/records/warning_letter/drg-instruments-gmbh/f83880cb-3137-41a7-a911-c959bb809db4)
- [WARNING_LETTER - 2024-11-07](https://www.keypedia.com/records/warning_letter/drg-instruments-gmbh/51bbefc6-dc80-4832-abad-5469bb43fafb)

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/drg-instruments-gmbh/5a8981ef-7bb3-4af6-a73f-01be1234ce51

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4