FDA Inspection
Roche Molecular Systems IncRoche Molecular Systems Inc – FDA Inspection, Sep 20, 2012
Record Details
This FDA Inspection record concerns Roche Molecular Systems Inc, with an inspection on September 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Roche Molecular Systems Inc
- Inspection Date
- September 20, 2012
- Product Type
- Devices
View Company Profile
ID · fafd415e-c69f-421e-bcca-fc07b2991660
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799345
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Roche Molecular Systems Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Roche Molecular Systems Inc
- FDA Inspection 1024093 - 2017-08-23
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.