FEI 3001814066
Paragon Medical Inc.
7350 E. 86TH ST., Castleton, IN, US
MDR events1All time
Recalls0All time
Registered products35
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
35 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 3001814066.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)May 20, 2025
Compliance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.75(a)May 20, 2025
Lack of or inadequate process validation
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.