Freeland Systems, Llc
550 Congressional Blvd Ste 115, Carmel, IN, US
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 3017697447.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Jul 17, 2026
Compliance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
1ISO 13485:2016 Clause 4.2.5Procedures for control of records not documented
1ISO 13485:2016 Clause 5.6.1Management review procedures not documented
1ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
1ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
1ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
1
- ISO 13485:2016 Clause 4.2.3Jul 17, 2026
Medical device file not established and maintained
- ISO 13485:2016 Clause 4.2.5Jul 17, 2026
Procedures for control of records not documented
- ISO 13485:2016 Clause 5.6.1Jul 17, 2026
Management review procedures not documented
- ISO 13485:2016 Clause 7.3.9Jul 17, 2026
Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.4.1Jul 17, 2026
Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.4Jul 17, 2026
Internal audit procedures not documented
- ISO 13485:2016 Clause 8.4Jul 17, 2026
Procedures for analysis of data 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.