Genezen
Indianapolis, IN · Lexington, MA
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
71.5
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: Genezen
- Signal Score
- 71.5/100 (as of 2026-09-07)
- Quality Compliance
- 85.8/100
- Headquarters
- Indianapolis, IN · Lexington, MA
- Modalities
- AAV, Lentiviral
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Genezen
Mid-tier AAV/lentiviral specialist.
Signal Score & Pillar Breakdown
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
85.8
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-08-27)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, Lentiviral
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
58.0
Capacity status: Available
StatusAvailable
Genezen FDA Inspection History
2025-08
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-08-27 |
GENEZEN MA, INC.
Lexington, Massachusetts
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 2026
Attribution not established
(2)
These records are excluded from this company’s established evidence
because their attribution is unresolved. This describes an evidence-linking
limitation, not an assessment of the underlying regulatory findings.
| Source | Establishment named by the regulator | Location | Identifier |
|---|---|---|---|
| FDA inspection | Geneva Laboratories, Inc | Elkhorn, Wisconsin | FDA/FEI=2182801 |
| FDA inspection | Dee Cee Laboratories, Inc | White House, Tennessee | FDA/FEI=1023013 |
Source records retained verbatim · attribution not established
Frequently Asked Questions About Genezen
How many FDA inspections does Genezen have on record?
CDMO Signal tracks 1 FDA inspection for Genezen, sourced from the FDA inspection database. See the full inspection history above.
Has Genezen received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Genezen.
What is Genezen's CDMO Signal Score?
Genezen has a Signal Score of 72/100, based on quality, operations, financial stability, and capacity data.
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