Cincinnati Children's Vector Production Facility

Cincinnati, OH

National Center

AAV Lentiviral

1 confirmed programs · 1 sponsors · Last scored 2026-04-29

75.2

Signal Score

✓ FDA Inspections (1) ✓ Clinical Trials (1) ○ SEC Filings ○ Press ○ EMA GMP ○ MHRA GMP

Quick Facts: Cincinnati Children's Vector Production Facility

Signal Score: 75.2/100 (as of 2026-04-29)
Quality Compliance: 100.0/100
Headquarters: Cincinnati, OH
Modalities: AAV, Lentiviral
Active Programs: 1 confirmed from ClinicalTrials.gov across 1 sponsors
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

About Cincinnati Children's Vector Production Facility

CDMO.

Signal Score & Pillar Breakdown

Quality Compliance

FDA Inspections1 on record

Warning Letters0

Last InspectionNo Action Indicated (NAI) (2025-02-05)

Operations

1 active programs across 1 sponsors · Modalities: AAV, Lentiviral · 1 programs in advanced phases (Phase 2/3)

Programs 1

Sponsors1

ModalitiesAAV, Lentiviral

1 active programs across 1 sponsors

Modalities: AAV, Lentiviral

1 programs in advanced phases (Phase 2/3)

Source: ClinicalTrials.gov facility matching

NCT00537394 Optimizing Treatment for Treatment-Experienced, HIV-Infected People PHASE3 Completed

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Parent company: Cincinnati Children's Hospital

Financial assessment: 68.0/100

Capacity

1 manufacturing site

1 manufacturing site: Cincinnati, OH

Modalities: AAV, Lentiviral

Capacity assessment: 58.0/100

Cincinnati Children's Vector Production Facility FDA Inspection History

2025-02

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-02-05	Cincinnati, Ohio	Human Cellular, Tissue, and Gene Therapies	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved Jul 04, 2026

Cincinnati Children's Vector Production Facility FDA 483 Findings 1 observations · 2025-08-15 → 2025-08-15 ?

By subsystem

Documentation & Records 1 (100.0%)

By severity

2 — Minor: 1
Repeat observations: 0

Most severe findings

Minor (2) Documentation & Records 2025-08-15 21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

"Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established."

About this data →

Clinical Activity 1 studies

NCT00537394 Optimizing Treatment for Treatment-Experienced, HIV-Infected People PHASE3 Completed

Source: ClinicalTrials.gov · Retrieved Jul 04, 2026

Frequently Asked Questions About Cincinnati Children's Vector Production Facility

How many FDA inspections does Cincinnati Children's Vector Production Facility have on record?

CDMO Signal tracks 1 FDA inspection for Cincinnati Children's Vector Production Facility, sourced from the FDA inspection database. See the full inspection history above.

Has Cincinnati Children's Vector Production Facility received an FDA warning letter?

CDMO Signal has no FDA warning letters on record for Cincinnati Children's Vector Production Facility.

How many clinical programs is Cincinnati Children's Vector Production Facility linked to?

Cincinnati Children's Vector Production Facility is associated with 1 clinical trial in CDMO Signal's ClinicalTrials.gov-sourced data.

What is Cincinnati Children's Vector Production Facility's CDMO Signal Score?

Cincinnati Children's Vector Production Facility has a Signal Score of 75/100, based on quality, operations, financial stability, and capacity data.

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