FEI 3008773560
Biogennix, Llc
18009 Sky Park Cir Ste K, Irvine, CA, US
MDR events5All time
Recalls0All time
Registered products15
Establishment typeManufactureManufacture Medical Device
Registered product codes
15 product codes
Recent MDR events
5 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3008773560.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 8, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 8, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(a)Feb 8, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(a)Feb 8, 2024
Lack of or inadequate procedures
- 21 CFR 820.198(a)Feb 8, 2024
Complaints
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.