Cg Bio Co., Ltd.
Part of C-dong, Part of D-dong, Hwaseong-si Gyeonggi, KR
Registered product codes
13 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 3017036472.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Sep 11, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 11, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.70(e)Sep 11, 2025
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.184Sep 11, 2025
DHR - not or inadequately maintained
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
5 on file
Top refusal reasons
Compare to industry ↗- Division of Southeast Imports (DSEI)Aug 11, 2026
79LMH \ IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
- Division of Southwest Imports (DSWI)Nov 29, 2024
79LMH \ IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
- Division of Southwest Imports (DSWI)Nov 29, 2024
79LMH \ IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
- Division of Southeast Imports (DSEI)Jul 1, 2024
79LMH \ IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
- Division of Southeast Imports (DSEI)Apr 3, 2024
79OMP \ NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP