FDA Inspection
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA Inspection, Jun 29, 2018
Record Details
This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on June 29, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · dee24e9a-56d6-4527-a294-e947091d2bde
Inspection Facts
- Inspection number
- 1059197
- FDA center
- Human Drugs
- Outcome
- Form 483 issued
Other FDA inspections of Roche Diagnostics GmbH
13| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | Not classified | Office of Inspections and Investigations | Blood and Blood Products |
| May 22, 2025 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2023 | Not classified | Office of Inspections and Investigations | |
| September 16, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Roche Diagnostics GmbH
- FDA Inspection 1277484 - 2025-08-01
- FDA Inspection 1290452 - 2025-05-22
- FDA Inspection 1199547 - 2023-03-10
- FDA Inspection 1137525 - 2020-09-16
- FDA Inspection 1054436 - 2018-04-12
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