FEI 3011142981
Rontis Hellas S.a.
Industrial Area of Larisa, Larisa Thessalia, GR
MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3011142981.
FDA inspections
1 on file
- Official Action Indicated (OAI)Jul 25, 2024
Compliance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)Jul 25, 2024
Lack of or inadequate process validation
- 21 CFR 820.100(a)Jul 25, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jul 25, 2024
Lack of or inadequate complaint procedures
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.