Domico Med-device, Llc
14241 N. Fenton RD, Fenton, MI, US
Registered product codes
25 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 1825560.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 12, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 12, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.35(a)Records of complaint investigations do not include required information
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.5.1Production controls not adequate
1ISO 13485:2016 Clause 7.6Monitoring and measurement requirements not determined
1ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
1ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
1
- 21 CFR 820.35(a)May 12, 2026
Records of complaint investigations do not include required information
- ISO 13485:2016 Clause 7.1May 12, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.1May 12, 2026
Production controls not adequate
- ISO 13485:2016 Clause 7.6May 12, 2026
Monitoring and measurement requirements not determined
- ISO 13485:2016 Clause 8.2.2May 12, 2026
Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.5.2May 12, 2026
Corrective action procedures not documented
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.