FEI 1511629
Surgical Appliance Industries, Inc.
3960 ROSSLYN DR., CINCINNATI, OH, US
MDR events0All time
Recalls0All time
Registered products30
Establishment typeManufactureManufacture Medical Device
Registered product codes
30 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 1511629.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 18, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 18, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(a)Oct 18, 2023
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Oct 18, 2023
Lack of or inadequate procedures
- 21 CFR 820.198(a)Oct 18, 2023
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.