FEI 3004126239
Merchsource Llc
7755 Irvine Center Drive, Irvine, CA, US
MDR events1All time
Recalls1All time
Registered products12
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
12 product codes
Recent MDR events
1 on file
Compliance history
Matched by FEI 3004126239.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 22, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 22, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(j)Oct 22, 2025
Design history file
- 21 CFR 820.40Oct 22, 2025
Lack of procedures, or not maintained
- 21 CFR 820.100(a)Oct 22, 2025
Lack of or inadequate procedures
- 21 CFR 820.184Oct 22, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Oct 22, 2025
Lack of or inadequate complaint 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.