Ziip Inc
1910 Mark Ct, Concord, CA, US
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 3029740697.
FDA inspections
2 on file
- Official Action Indicated (OAI)Jan 12, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jan 12, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
8 on file
Top cited requirements
Compare to industry ↗21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
221 CFR 803.50(a)(2)Individual Report of Malfunction
121 CFR 820.30(f)Design verification - output does not meet input requirement
121 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
121 CFR 820.100(a)Lack of or inadequate procedures
121 CFR 820.181DMR - not or inadequately maintained
1
- 21 CFR 803.50(a)(2)Jan 12, 2026
Individual Report of Malfunction
- 21 CFR 820.30(f)Jan 12, 2026
Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Jan 12, 2026
Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Jan 12, 2026
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Jan 12, 2026
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.100(a)Jan 12, 2026
Lack of or inadequate procedures
- 21 CFR 820.181Jan 12, 2026
DMR - not or inadequately maintained
- 21 CFR 820.198(a)Jan 12, 2026
Lack of or inadequate complaint procedures
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.