Anexa Biomedical, Inc.
7201 Iron Horse Blvd., North Richland Hills, TX, US
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 3027590916.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Jun 10, 2026
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.1.5External party controls do not include written quality agreements
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.5.6Records of validation of processes and necessary actions not maintained
1ISO 13485:2016 Clause 8.5.2Corrective action not taken
1
- ISO 13485:2016 Clause 4.1.5Jun 10, 2026
External party controls do not include written quality agreements
- ISO 13485:2016 Clause 7.1Jun 10, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.6Jun 10, 2026
Records of validation of processes and necessary actions not maintained
- ISO 13485:2016 Clause 8.5.2Jun 10, 2026
Corrective action not taken
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.