FDA Inspection
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA Inspection, Aug 29, 2019
Record Details
This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on August 29, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eb428e12-856a-41e1-9954-fd28c50f150f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103444
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
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 |
| June 19, 2018 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| April 19, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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 1057635 - 2018-06-19
- FDA Inspection 1057452 - 2018-04-19
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