FEI 3016842367
Solevy Co. Llc
29017 Avenue Penn, Santa Clarita, 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 3016842367.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 12, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 12, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 801.20(a)Feb 12, 2024
Label to bear a unique device identifier
- 21 CFR 820.30(e)Feb 12, 2024
Design review - documentation
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.