FEI 3013012623
Viscus Biologics, Llc.
26309 Miles Road, Cleveland, OH, US
MDR events1All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
4 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 3013012623.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 9, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 9, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(c)May 9, 2024
Design input - documentation
- 21 CFR 820.30(g)May 9, 2024
Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(b)May 9, 2024
Lack/Inad procedure-Monitoring/Control of Validated Proces
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.