Jardon Eye Prosthetics, Inc.
15920 W. 12 MILE ROAD, SOUTHFIELD, MI, US
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 1824736.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 2, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 2, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.2.4Lack of document control
1ISO 13485:2016 Clause 5.5.1Management responsibilities and authorities not documented
1ISO 13485:2016 Clause 5.6.1Management review procedures not documented
1ISO 13485:2016 Clause 6.3Requirements for infrastructure maintenance activities not documented
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
1
- ISO 13485:2016 Clause 4.2.4Mar 2, 2026
Lack of document control
- ISO 13485:2016 Clause 5.5.1Mar 2, 2026
Management responsibilities and authorities not documented
- ISO 13485:2016 Clause 5.6.1Mar 2, 2026
Management review procedures not documented
- ISO 13485:2016 Clause 6.3Mar 2, 2026
Requirements for infrastructure maintenance activities not documented
- ISO 13485:2016 Clause 7.1Mar 2, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Mar 2, 2026
Criteria for the evaluation and selection of suppliers not established
- ISO 13485:2016 Clause 8.2.4Mar 2, 2026
Internal audit procedures not documented
- ISO 13485:2016 Clause 8.3.1Mar 2, 2026
Procedure for nonconforming product 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.