FEI 3030691709
Nextbeam
301 Centennial Dr Ste 200, North Sioux City, SD, US
MDR events0All time
Recalls0All time
Registered products7
Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)
Registered product codes
7 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 3030691709.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 13, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 13, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Mar 13, 2025
Lack of Written MDR Procedures
- 21 CFR 820.198(a)Mar 13, 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.