FEI 3010128826
Ls Investment Ii
38205 Western Pkwy, Willoughby, OH, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
3 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 3010128826.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 30, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 30, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(a)Oct 30, 2024
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(b)Oct 30, 2024
Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Oct 30, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Oct 30, 2024
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.