Defibtech Branford
14 Commercial St, Branford, CT, US
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 3012972516.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 25, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 25, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
121 CFR 830.310(b)GUDID Information required for unique device identification.
1
- 21 CFR 820.50Mar 25, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Mar 25, 2025
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Mar 25, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Mar 25, 2025
Lack of or inadequate complaint procedures
- 21 CFR 830.310(b)Mar 25, 2025
GUDID Information required for unique device identification.
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.