FEI 3009560097
Novaf Andalucia 2007, S.l.
Pol. Ind. Santa Teresa, nave 1, Rota Cadiz, ES
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 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 3009560097.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Mar 12, 2024
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Mar 12, 2024
Lack of Written MDR Procedures
- 21 CFR 820.30(a)Mar 12, 2024
Design control - no procedures
- 21 CFR 820.70(a)Mar 12, 2024
Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.100(a)Mar 12, 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.