Medynus, Inc.
18 Technology Dr. Suite 109, Irvine, CA, 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 3015426608.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Dec 17, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Dec 17, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.22Quality Audit/Reaudit - conducted
121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
121 CFR 820.50(a)(2)Supplier oversight
121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.198(a)Lack of or inadequate complaint procedures
1
- 21 CFR 820.22Dec 17, 2024
Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Dec 17, 2024
Design validation- Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Dec 17, 2024
Supplier oversight
- 21 CFR 820.80(b)Dec 17, 2024
Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Dec 17, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Dec 17, 2024
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.