CellGenix
Freiburg, DE
Reagent / Material Supplier
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
56.5
Signal Score
○ FDA Inspections
○ Clinical Trials
○ SEC Filings
✓ Press (1)
○ EMA GMP
○ MHRA GMP
Quick Facts: CellGenix
- Signal Score
- 56.5/100 (as of 2026-04-29)
- Quality Compliance
- Assessment pending
- Headquarters
- Freiburg, DE
- Modalities
- Cell Therapy
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About CellGenix
Reagent/raw material supplier.
Signal Score & Pillar Breakdown
Quality Compliance
—
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
FDA InspectionsNo US records on file
No FDA inspection records found for this manufacturer
Quality score requires FDA inspection data
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCell Therapy
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity
53.0
1 manufacturing site: Freiburg, DE
Modalities: Cell Therapy
Capacity assessment: 53.0/100
Sites: Freiburg, DE
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press1 articles
1 manufacturing site: Freiburg, DE
Modalities: Cell Therapy
Capacity assessment: 53.0/100
FDA 483 Findings 3 observations · 2025-12-19 → 2025-12-19 ?
By subsystem
By severity
- 2 — Minor: 3
- Repeat observations: 0
Most severe findings
-
Quality control operations - packaged, labeled; specifications
"Your quality control operations did not include determining whether the finished packaged and labeled dietary supplement conforms to established specifications."
-
Production, process controls - implement
"You did not implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure."
-
Records - available; FDA
"You did not have required records, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested."
Recent News 1 articles
GMP Cytokines Market to Grow at 8.4% CAGR Through 2032 | Bio-Techne, PeproTech, CellGenix, Miltenyi Biotec - openPR.com
GMP Cytokines Market to Grow at 8.4% CAGR Through 2032 | Bio-Techne, PeproTech, CellGenix, Miltenyi Biotec openPR.com
Represent this organization? Contact us to verify or update this profile.
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