FEI 1000115048Initial importer
Phoenix Instruments, Inc.
4985 Varsity Dr, Lisle, IL, US
MDR events0All time
Recalls0All time
Registered products270
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
270 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 1000115048.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 30, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)May 30, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(a)May 30, 2025
Management ensuring quality policy is understood
- 21 CFR 820.100(b)May 30, 2025
Documentation
- 21 CFR 820.198(a)May 30, 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.