FEI 1000480800
Bertec Corp.
2500 Citygate Drive, COLUMBUS, OH, US
MDR events0All time
Recalls0All time
Registered products5
Establishment typeManufactureManufacture Medical Device
Registered product codes
5 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 1000480800.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 12, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 12, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50Feb 12, 2024
Purchasing controls, 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.