FDA Inspection
Roche Diagnostics GmbHRoche Diagnostics GmbH – FDA Inspection, Apr 4, 2014
Record Details
This FDA Inspection record concerns Roche Diagnostics GmbH, with an inspection on April 4, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Roche Diagnostics GmbH
- Inspection Date
- April 4, 2014
- Product Type
- Drugs
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ID · cc537ebf-bc7c-4029-8a74-7840d4b2b0a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 874281
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 211.113(b)Procedures for sterile drug products
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 |
| 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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