FEI 3004964590
Avox Systems
225 Erie St, Lancaster, NY, 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 3004964590.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 2, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 2, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)Feb 2, 2024
Lack of or inadequate process validation
- 21 CFR 830.300(a)Feb 2, 2024
Devices subject to device identification GUDID data submission requirements.
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.