FDA Inspection
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA Inspection, Jun 19, 2018
Record Details
This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on June 19, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
View Company Profile
ID · ff707855-9494-46db-9f89-c5cc6cddc7f0
Inspection Facts
- Inspection number
- 1057635
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
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 |
| 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 1103444 - 2019-08-29
- FDA Inspection 1057452 - 2018-04-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.