# FDA 483 - Roche Diagnostics GmbH - August 01, 2025

Source: https://www.keypedia.com/records/483/roche-diagnostics-gmbh/bebca28c-5fa2-42b5-a72f-fb536d469d06

> FDA 483 for Roche Diagnostics GmbH on August 01, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roche Diagnostics GmbH
- Inspection Date: 2025-08-01
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Roche Diagnostics GmbH in Penzberg, Germany, received a Form 483 with two observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within 30 days for Elecsys products that produced false reactive test results. Additionally, their procedures for receiving, reviewing, and evaluating complaints were found to be inadequate.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/roche-diagnostics-gmbh/06ecc49c-2224-462e-b964-933d319f0b17)

## Related Officers

- [Cody D. Rickman](https://www.keypedia.com/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)
- [investigator](https://www.keypedia.com/people/mizanne-e-lewis/c79964ac-5163-44a2-89e9-8cc8775de9b4)

Company: https://www.keypedia.com/companies/roche-diagnostics-gmbh/a09aff2c-624a-48aa-b33e-fae16aa146f8

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8