Marine Polymer Technologies, Inc.
461 BOSTON ST., UNIT B5, TOPSFIELD, MA, 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 3001237365.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 6, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 6, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 4.1.4Changes to the QMS not adequately controlled or evaluated
1ISO 13485:2016 Clause 6.2(e)Records of personnel competence not maintained
1ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
1ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
1
- ISO 13485:2016 Clause 4.1.4Jul 6, 2026
Changes to the QMS not adequately controlled or evaluated
- ISO 13485:2016 Clause 6.2(e)Jul 6, 2026
Records of personnel competence not maintained
- ISO 13485:2016 Clause 8.2.2Jul 6, 2026
Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.3.1Jul 6, 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.