Celltrion Pharm
South Korea
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (6)
Quick Facts: Celltrion Pharm
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- South Korea
- Website
- https://celltrionph.com/ko-kr/home/index
- Modalities
- Biologics, Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Celltrion Pharm
Celltrion Pharm makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Biologics, Oral Solid Dose. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://celltrionph.com/ko-kr/home/index
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Celltrion Pharm FDA Inspection History
2024-07
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2024-07-23 |
Celltrion Pharm, Inc.
Cheongju
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Celltrion Pharm FDA 483 Findings 3 observations · 2023-09-14 → 2023-09-14 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been adequately established."
-
Management review - Lack of or inadequate procedures
"Procedures for management review have not been adequately established."
-
Lack of or inadequate final acceptance procedures
"Procedures for finished device acceptance have not been adequately established."
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 yet. We haven't found a public jobs feed for this company.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About Celltrion Pharm
How many FDA inspections does Celltrion Pharm have on record?
CDMO Signal tracks 1 FDA inspection for Celltrion Pharm, sourced from the FDA inspection database. See the full inspection history above.
Has Celltrion Pharm received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Celltrion Pharm.
Does Celltrion Pharm have a CDMO Signal Score?
Not yet. Celltrion Pharm is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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