FEI 3010351679
Blephex, Llc
500 Wilson Pike Circle, Brentwood, TN, US
MDR events4All time
Recalls0All time
Registered products6
Establishment typeManufactureManufacture Medical Device
Registered product codes
6 product codes
Recent MDR events
4 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3010351679.
FDA inspections
2 on file
- Official Action Indicated (OAI)Nov 19, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Nov 19, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Nov 19, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Nov 19, 2025
Training - Lack of or inadequate procedures
- 21 CFR 820.30(a)Nov 19, 2025
Design control - no procedures
- 21 CFR 820.50(a)(2)Nov 19, 2025
Supplier oversight
- 21 CFR 820.100(b)Nov 19, 2025
Documentation
- 21 CFR 820.184Nov 19, 2025
Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Nov 19, 2025
Complaints
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.