FEI 3000538043
Stoner Incorporated
1070 Robert Fulton Hwy, Quarryville, PA, US
MDR events0All time
Recalls0All time
Registered products2
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
2 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 3000538043.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 15, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 15, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(b)(3)(i)Nov 15, 2023
Management representative implementing the quality system
- 21 CFR 820.181Nov 15, 2023
DMR - not or inadequately maintained
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.