Audifon - Gmbh & Co.kg
WERNER-VON-SIEMENS-STRABE 2, KOLLEDA Thuringia, DE
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 3006076696.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jan 16, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 16, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 820.30(g)Jan 16, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Jan 16, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Jan 16, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Jan 16, 2025
Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(a)Jan 16, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jan 16, 2025
Lack of or inadequate complaint 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.