# FDA 483 - Roche Diagnostics GmbH - August 29, 2019

Source: https://www.globalkeysolutions.net/records/483/roche-diagnostics-gmbh/9da37e28-334c-4e14-b8b6-43bef01ce192

> FDA 483 for Roche Diagnostics GmbH on August 29, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roche Diagnostics GmbH
- Inspection Date: 2019-08-29
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Roche Diagnostics GmbH in Mannheim, Germany, was cited for failing to submit a Medical Device Report (MDR) within 30 days for a device malfunction. The inspection also found that the firm did not adequately investigate other complaints to determine reportability. This indicates issues with their post-market surveillance and complaint handling processes.

## Related Officers

- [Chaudhry Din](https://www.globalkeysolutions.net/people/chaudhry-din/037de42d-c8c0-4bb3-a85d-db6e021de07c)
- [Matthew D. Admire](https://www.globalkeysolutions.net/people/matthew-d-admire/292e0983-d5de-40eb-a2da-4b990a532047)

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-gmbh/a23249df-90f8-49fa-8a07-267a69157488

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