FDA Inspection
Roche Molecular Systems, Inc.Roche Molecular Systems, Inc. – FDA Inspection, Jan 27, 2011
Record Details
This FDA Inspection record concerns Roche Molecular Systems, Inc., with an inspection on January 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 27, 2011
- Product Type
- Biologics
View Company Profile
ID · f0046bd5-28cb-41ca-89c4-133837a6db6a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 707713
- FDA center
- Biologics
- Project area
- Blood and Blood Products
Other FDA inspections of Roche Molecular Systems, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2026 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 8, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 31, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 24, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 19, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Roche Molecular Systems, Inc.
- FDA Inspection 1323692 - 2026-06-12
- FDA Inspection 1224711 - 2023-12-08
- FDA Inspection 1100926 - 2019-07-31
- FDA Inspection 1027092 - 2017-07-24
- FDA Inspection 1020421 - 2017-07-19
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