FEI 1000160571
Rolenn Manufacturing, Inc.
1549 Marlborough Ave, Riverside, CA, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
1 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 1000160571.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Dec 5, 2024
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.25(b)Dec 5, 2024
Training - Lack of or inadequate procedures
- 21 CFR 820.75(a)Dec 5, 2024
Lack of or inadequate process validation
- 21 CFR 820.80(d)Dec 5, 2024
Lack of or inadequate final acceptance procedures
- 21 CFR 820.100(a)Dec 5, 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.