FDA Inspection
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA Inspection, Jul 14, 2023
Record Details
This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on July 14, 2023, issued by the Office of Inspections and Investigations.
- Company
- Roche Diagnostics GmbH
- Inspection Date
- July 14, 2023
View Company Profile
ID · a0f27491-5e3a-4d48-8601-ea67f5698f18
Inspection Facts
- Inspection number
- 1210168
- FDA center
- Human Drugs
- 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 | |
| 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 |
| 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 1177109 - 2021-10-29
- FDA Inspection 1103444 - 2019-08-29
- FDA Inspection 1057635 - 2018-06-19
- FDA Inspection 1057452 - 2018-04-19
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