FEI 3005157180
Gexfix Sa
Chemin Du Pavillon 2, Le Grand-Saconnex Geneve, CH
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 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 3005157180.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 21, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Nov 21, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Nov 21, 2024
Design validation - user needs and intended uses
- 21 CFR 820.75(a)Nov 21, 2024
Lack of or inadequate process validation
- 21 CFR 820.100(a)Nov 21, 2024
Lack of or inadequate procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.