Marlen Mfg. & Development Co.
5150 RICHMOND RD., BEDFORD, OH, US
Registered product codes
5 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 1520020.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)May 6, 2026
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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 7.5.6Procedures for validation of processes not documented
1
- 21 CFR 830.300(a)May 6, 2026
Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.1May 6, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.5.1May 6, 2026
Production controls not adequate
- ISO 13485:2016 Clause 7.5.6May 6, 2026
Procedures for validation of processes 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.