FEI 3013398027
Tobra Medical, Inc.
3200 Wellington Court, Raleigh, NC, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
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 3013398027.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 19, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 19, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Nov 19, 2025
Quality Audit/Reaudit - conducted
- 21 CFR 820.25(b)Nov 19, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.40Nov 19, 2025
Procedures not adequately established or maintained
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.