FEI 1000160162Initial importer
Wexler Surgical, Inc.
11333 Chimney Rock Rd Suite 110-120, HOUSTON, TX, US
MDR events1All time
Recalls0All time
Registered products132
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
132 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 1000160162.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 30, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 30, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(g)Jul 30, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Jul 30, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.100(b)Jul 30, 2025
Documentation
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.