FEI 3015239144
Mrpc
13161 W. Glendale, Butler, WI, 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 3015239144.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 16, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 16, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50Dec 16, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Dec 16, 2024
Lack of or inadequate process validation
- 21 CFR 820.90(a)Dec 16, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Dec 16, 2024
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.