FEI 3022140316
Polyganics Holding Bv
Blauwborgje 32, Groningen, NL
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
4 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 3022140316.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 4, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 4, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.40Sep 4, 2025
Procedures not adequately established or maintained
- 21 CFR 820.75(a)Sep 4, 2025
Lack of or inadequate process validation
- 21 CFR 820.100(a)Sep 4, 2025
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.