Orfit Industries Nv
9A, VOSVELD, WIJNEGEM Antwerpen, BE
Registered product codes
16 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 1000227792.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Apr 2, 2026
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
1ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
1ISO 13485:2016 Clause 7.5.6Procedures for validation of processes lack required elements
1ISO 13485:2016 Clause 7.6Procedures for monitoring and measuring equipment requirements not documented
1
- ISO 13485:2016 Clause 4.2.4Apr 2, 2026
Document Control Procedure Inadequate
- ISO 13485:2016 Clause 7.5.1Apr 2, 2026
Production and service provision not adequate
- ISO 13485:2016 Clause 7.5.6Apr 2, 2026
Procedures for validation of processes lack required elements
- ISO 13485:2016 Clause 7.6Apr 2, 2026
Procedures for monitoring and measuring equipment requirements not documented
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.