FEI 1045379Initial importer
Stephens Instruments, Inc
2500 Sandersville Rd, LEXINGTON, KY, US
MDR events0All time
Recalls0All time
Registered products53
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
53 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 1045379.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Oct 26, 2023
Compliance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50Oct 26, 2023
Purchasing controls, Lack of or inadequate 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.