Genezen

Indianapolis, IN · Lexington, MA

AAV Lentiviral

Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29

70.9

Signal Score

✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Genezen

Signal Score: 70.9/100 (as of 2026-04-29)
Quality Compliance: 84.4/100
Headquarters: Indianapolis, IN · Lexington, MA
Modalities: AAV, Lentiviral
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

Mid-tier AAV/lentiviral specialist.

Quality Compliance

FDA Inspections3 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2025-11-04)

Operations —

No ClinicalTrials.gov facility matches confirmed for this manufacturer.

Programs — no verified data

Sponsors— no verified data

ModalitiesAAV, Lentiviral

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

Profile-based financial assessment

SEC FilingsPrivate company

Private company

Financial assessment: 60.0/100

Capacity

1 manufacturing site

Status

1 manufacturing site: Indianapolis, IN

Modalities: AAV, Lentiviral

Capacity assessment: 58.0/100

2025-11

2025-08

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-11-04	Elkhorn, Wisconsin	Drug Quality Assurance	Yes	Voluntary Action Indicated (VAI)
2025-08-27	Lexington, Massachusetts	Human Cellular, Tissue, and Gene Therapies	No	No Action Indicated (NAI)
2025-08-11	White House, Tennessee	Drug Quality Assurance	Yes	Voluntary Action Indicated (VAI)

Source: FDA Data Dashboard · Retrieved May 20, 2026

Documentation & Records 4 (33.3%)
Equipment & Facilities 3 (25.0%)
Other 2 (16.7%)
Laboratory Controls 1 (8.3%)
Data Integrity 1 (8.3%)
CAPA 1 (8.3%)

Critical (5) Data Integrity 2025-11-04 21 CFR 211.68(b)

Computer control of master formula records

"Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel."
Moderate (3) Laboratory Controls 2025-08-11 21 CFR 211.166(c)(1)

Homeopathic drugs, assessment of stability

"There is no written assessment of stability of homeopathic drug products based at least on testing or examination of the drug product for compatibility of the ingredients."
Moderate (3) CAPA 2025-08-11 21 CFR 211.180(e)(2)

Review of problem drugs

"The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of complaint, recall, returned drug product, salvaged drug product and investigation records for each drug product."