CKD BiO
Ansan, South Korea
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (4)
Quick Facts: CKD BiO
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Ansan, South Korea
- Website
- https://www.ckdbio.com/
- Modalities
- Microbial Fermentation, Small Molecule API, Intermediates
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About CKD BiO
CKD BiO makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Microbial Fermentation, Small Molecule API, Intermediates. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.ckdbio.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
CKD BiO FDA Inspection History
2025-11
2023-09
2022-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-07 |
CKD Bio Corporation
Ansan
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-09-15 |
CKD Bio Corporation
Ansan
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-11-18 |
CKD Bio Corporation
Ansan
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Nov 01, 2026
Hiring Activity Beta
Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source:
public careers pages
· Checked Oct 31, 2026
Frequently Asked Questions About CKD BiO
How many FDA inspections does CKD BiO have on record?
CDMO Signal tracks 3 FDA inspections for CKD BiO, sourced from the FDA inspection database. See the full inspection history above.
Has CKD BiO received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for CKD BiO.
Does CKD BiO have a CDMO Signal Score?
Not yet. CKD BiO is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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