FEI 3011499019
Band Connect
1116 Race Street, Cincinnati, OH, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
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 3011499019.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 12, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 12, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)Dec 12, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.30(a)Dec 12, 2025
Design control - no procedures
- 21 CFR 820.100(a)Dec 12, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Dec 12, 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.