FEI 3002303166
Kent Elastomer Products, Inc.
1500 Saint Clair Ave, KENT, OH, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
2 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 3002303166.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Oct 16, 2025
Compliance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50Oct 16, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(b)Oct 16, 2025
Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.100(a)Oct 16, 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.