FEI 3000205591
Nginstruments, Inc Dba Avalign Cutting Instruments
4643 N State Road 15, Warsaw, IN, US
MDR events0All time
Recalls0All time
Registered products77
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
77 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 3000205591.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 14, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 14, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)Dec 14, 2023
Lack of or inadequate process validation
- 21 CFR 820.80(c)Dec 14, 2023
Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Dec 14, 2023
Nonconforming product, Lack of or inadequate 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.