FEI 1833387
Serim Research Corp.
3506 Reedy Dr, ELKHART, IN, US
MDR events0All time
Recalls0All time
Registered products10
Establishment typeManufactureManufacture Medical Device
Registered product codes
10 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 1833387.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 30, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 30, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Jul 30, 2025
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)Jul 30, 2025
Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.72(a)Jul 30, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Jul 30, 2025
Sampling plans
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.