FDA Inspection
Icare Finland OyIcare Finland Oy – FDA Inspection, Apr 22, 2015
Record Details
This FDA Inspection record concerns Icare Finland Oy, with an inspection on April 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Icare Finland Oy
- Inspection Date
- April 22, 2015
- Product Type
- Devices
View Company Profile
ID · 51d535a8-a2f9-4561-a8dc-56fcc535f6d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927346
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Icare Finland Oy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Icare Finland Oy
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.