FDA Inspection
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on November 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fa494974-fb58-4611-9be9-d37ef7922879
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 993103
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Roche Diagnostics GmbH
15| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2024 | Not classified | Office of Inspections and Investigations | |
| July 14, 2023 | Not classified | Office of Inspections and Investigations | |
| October 29, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 19, 2018 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
Other documents for Roche Diagnostics GmbH
- FDA Inspection 1242676 - 2024-03-20
- FDA Inspection 1210168 - 2023-07-14
- FDA Inspection 1177109 - 2021-10-29
- FDA Inspection 1103444 - 2019-08-29
- FDA Inspection 1057635 - 2018-06-19
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