FEI 3008972967
Sim Med, Llc
N65W24770 Main St., Sussex, 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 3008972967.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 10, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 10, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Apr 10, 2025
Lack of Written MDR Procedures
- 21 CFR 820.50(a)(3)Apr 10, 2025
Acceptable supplier records, inadequate records
- 21 CFR 820.75(a)Apr 10, 2025
Lack of or inadequate process validation
- 21 CFR 820.75(b)Apr 10, 2025
Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.100(b)Apr 10, 2025
Documentation
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.