FEI 3006537560
Flextronics America, Llc
12455 Research Boulevard, Austin, TX, US
MDR events1All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
3 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3006537560.
FDA inspections
4 on file
- Official Action Indicated (OAI)Oct 30, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 30, 2025
Postmarket Assurance: Devices · Citations posted
- No Action Indicated (NAI)Sep 26, 2024
Compliance: Devices
- No Action Indicated (NAI)Sep 26, 2024
Postmarket Assurance: Devices
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)Oct 30, 2025
Lack of or inadequate process validation
- 21 CFR 820.80(a)Oct 30, 2025
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(b)Oct 30, 2025
Documentation
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.