# Roche Diagnostics GmbH - Inspection Records

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

> Inspection records and compliance data for Roche Diagnostics GmbH in Penzberg, None. Access full analysis and detailed observations.

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## Details

- Name: Roche Diagnostics GmbH
- FEI Number: 3002806560
- City: Penzberg
- State: None
- Country Name: Germany
- Address Line 1: Nonnenwald 2
- Zip Code: None

## Related Documents

- [483 - Roche Diagnostics GmbH - Unknown Date](https://www.keypedia.com/records/483/roche-diagnostics-gmbh/06ecc49c-2224-462e-b964-933d319f0b17) — source: FDA, date: Invalid Date
- [483 - Roche Diagnostics GmbH - 2025-08-01](https://www.keypedia.com/records/483/roche-diagnostics-gmbh/bebca28c-5fa2-42b5-a72f-fb536d469d06) — source: FDA, date: August 1, 2025
- [FDA Inspection 1277484 - Roche Diagnostics GmbH - 2025-08-01](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/b6047294-4f5d-4c5d-9fe7-d1733ea1967d) — source: FDA, date: August 1, 2025
- [FDA Inspection 1290452 - Roche Diagnostics GmbH - 2025-05-22](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/0325252f-5b8f-400b-b4b4-f039baa430ab) — source: FDA, date: May 22, 2025
- [FDA Inspection 1290452 - Roche Diagnostics GmbH - 2025-05-22](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/e66527d4-c20a-4b20-97f4-7407e4eb429a) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 22, 2025
- [483 - Roche Diagnostics GmbH - 2023-03-10](https://www.keypedia.com/records/483/roche-diagnostics-gmbh/a55e0790-80d7-4185-972d-db8f3900367c) — source: FDA, date: March 10, 2023
- [FDA Inspection 1199547 - Roche Diagnostics GmbH - 2023-03-10](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/6382bdc3-9037-4345-b2f8-2d537fabb357) — source: FDA, date: March 10, 2023
- [FDA Inspection 1137525 - Roche Diagnostics GmbH - 2020-09-16](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/c60109aa-2f32-4241-af2d-7b8bcd7e7d8d) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 16, 2020
- [FDA Inspection 1054436 - Roche Diagnostics GmbH - 2018-04-12](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/91dc71a0-abd9-449f-ad78-8f682ea10db5) — classification: No Action Indicated (NAI), source: FDA, date: April 12, 2018
- [FDA Inspection 1054436 - Roche Diagnostics GmbH - 2018-04-12](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/fdc66548-8f43-4aba-bf4d-c5929dac3064) — classification: No Action Indicated (NAI), source: FDA, date: April 12, 2018
- [FDA Inspection 975397 - Roche Diagnostics GmbH - 2016-04-29](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/d75bb678-727d-43df-afd8-c9393d2753a9) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 29, 2016
- [FDA Inspection 928456 - Roche Diagnostics GmbH - 2015-05-20](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/846ac9c8-a73d-417e-8ca4-f61a34a32200) — classification: No Action Indicated (NAI), source: FDA, date: May 20, 2015
- [FDA Inspection 881599 - Roche Diagnostics GmbH - 2014-05-16](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/02ad8315-d9f9-48e4-815a-a619f3ff4b16) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 16, 2014

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