FEI 3005021818
Medical Solutions International, Inc.
5646 MERRIAM DR, Shawnee Mission, KS, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 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 3005021818.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 15, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Apr 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(f)Apr 15, 2024
Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Apr 15, 2024
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Apr 15, 2024
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Apr 15, 2024
Design changes - Lack of or Inadequate Procedures
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.