FEI 3007544874
Custom Wire Technologies, Inc
1123 Mineral Springs Dr, Port Washington, WI, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
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 3007544874.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Jul 17, 2025
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(c)Jul 17, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Jul 17, 2025
Lack of or inadequate process validation
- 21 CFR 820.80(c)Jul 17, 2025
Documentation
- 21 CFR 820.90(a)Jul 17, 2025
Nonconforming product, 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.