# Roche Diagnostics GmbH, Mannheim, Germany – FDA Inspections

Source: https://www.keypedia.com/companies/roche-diagnostics-gmbh/a23249df-90f8-49fa-8a07-267a69157488

> Inspection records and compliance data for Roche Diagnostics GmbH in Mannheim. 16 FDA inspections on record, 5 Form 483s, last inspected March 20, 2024.

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## Details

- Name: Roche Diagnostics GmbH
- FEI Number: 3002806559
- Business Operations: API MANUFACTURE
- Address Line 1: Sandhofer Str. 116
- City: Mannheim
- Country Name: Germany
- Address: Sandhofer Str. 116, Mannheim, Germany
- Country: Germany

## Related Documents

- [FDA Inspection 1242676 - Roche Diagnostics GmbH - 2024-03-20](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/7561186e-7634-40c0-b662-e63a4a05354e) — source: FDA, date: March 20, 2024
- [FDA Inspection 1210168 - Roche Diagnostics GmbH - 2023-07-14](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/a0f27491-5e3a-4d48-8601-ea67f5698f18) — source: FDA, date: July 14, 2023
- FDA Inspection 1177109 - Roche Diagnostics GmbH - 2021-10-29 — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 29, 2021
- [483 - Roche Diagnostics GmbH - 2019-08-29](https://www.keypedia.com/records/483/roche-diagnostics-gmbh/9da37e28-334c-4e14-b8b6-43bef01ce192) — source: FDA, date: August 29, 2019
- FDA Inspection 1103444 - Roche Diagnostics GmbH - 2019-08-29 — classification: Voluntary Action Indicated (VAI), source: FDA, date: August 29, 2019
- [FDA Inspection 1103444 - Roche Diagnostics GmbH - 2019-08-29](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/eb428e12-856a-41e1-9954-fd28c50f150f) — classification: Voluntary Action Indicated (VAI), source: FDA, date: August 29, 2019
- [FDA Inspection 1057635 - Roche Diagnostics GmbH - 2018-06-19](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/ff707855-9494-46db-9f89-c5cc6cddc7f0) — source: FDA, date: June 19, 2018
- FDA Inspection 1057452 - Roche Diagnostics GmbH - 2018-04-19 — classification: No Action Indicated (NAI), source: FDA, date: April 19, 2018
- [FDA Inspection 993103 - Roche Diagnostics GmbH - 2016-11-18](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/fa494974-fb58-4611-9be9-d37ef7922879) — classification: No Action Indicated (NAI), source: FDA, date: November 18, 2016
- FDA Inspection 993103 - Roche Diagnostics GmbH - 2016-11-18 — classification: No Action Indicated (NAI), source: FDA, date: November 18, 2016
- [FDA Inspection 973782 - Roche Diagnostics GmbH - 2016-04-22](https://www.keypedia.com/records/fda_inspections/roche-diagnostics-gmbh/2c607e51-97b0-46ca-a050-c409d7bdb930) — classification: No Action Indicated (NAI), source: FDA, date: April 22, 2016

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