FDA Inspection
Menarini Silicon BiosystemsMenarini Silicon Biosystems – FDA Inspection, Oct 4, 2017
Record Details
This FDA Inspection record concerns Menarini Silicon Biosystems, with an inspection on October 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · bd0aa0df-45ac-4202-a96b-e8597e7f7bb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027679
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.86Acceptance status
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Menarini Silicon Biosystems
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Menarini Silicon Biosystems
- FDA Inspection 843542 - 2013-08-07
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.