FEI 3001237801Initial importer
Tex-care Medical
2908 Alamance Rd, Burlington, NC, US
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 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 3001237801.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Dec 15, 2023
Compliance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Dec 15, 2023
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Dec 15, 2023
Documentation
- 21 CFR 820.184Dec 15, 2023
Lack of or inadequate DHR 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.