FEI 3020749939Initial importer
Encore Laboratory
1520 BROOKHOLLOW DR, Santa Ana, CA, US
MDR events0All time
Recalls0All time
Registered products5
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
5 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 3020749939.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jan 9, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jan 9, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗- 21 CFR 801.20(a)Jan 9, 2026
Label to bear a unique device identifier
- 21 CFR 820.22Jan 9, 2026
Quality Audit/Reaudit - conducted
- 21 CFR 820.90(a)Jan 9, 2026
Nonconforming product control
- 21 CFR 820.184Jan 9, 2026
DHR content
- 21 CFR 820.198(a)Jan 9, 2026
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.