Kindeva Drug Delivery

Woodbury, MN

Biologics

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

74.5

Signal Score

✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ✓ Press (1) ○ EMA GMP ✓ MHRA GMP (3)

Quick Facts: Kindeva Drug Delivery

Signal Score: 74.5/100 (as of 2026-04-29)
Quality Compliance: 95.1/100
Headquarters: Woodbury, MN
Modalities: Biologics
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 Kindeva Drug Delivery

Pure-play CDMO.

Signal Score & Pillar Breakdown

Quality Compliance

FDA Inspections2 on record

Warning Letters0

Last InspectionVoluntary Action Indicated (VAI) (2025-11-13)

MHRA GMP Certificates3 on record

Operations —

No ClinicalTrials.gov facility matches confirmed for this manufacturer.

Programs — no verified data

Sponsors— no verified data

ModalitiesBiologics

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

Recent Press1 articles

1 manufacturing site: Woodbury, MN

Modalities: Biologics

Capacity assessment: 53.0/100

FDA Inspection History

2025-11

2025-03

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-11-13	Northridge, California	Drug Quality Assurance	Yes	Voluntary Action Indicated (VAI)
2025-03-14	Loughborough	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)

Source: FDA Data Dashboard · Retrieved May 20, 2026

FDA 483 Findings 2 observations · 2025-11-13 → 2025-11-13 ?

By subsystem

Documentation & Records 1 (50.0%)
CAPA 1 (50.0%)

By severity

3 — Moderate: 1
2 — Minor: 1
Repeat observations: 0

Most severe findings

Moderate (3) CAPA 2025-11-13 21 CFR 211.192

No written record of investigation

"Written records are not always made of investigations into unexplained discrepancies."
Minor (2) Documentation & Records 2025-11-13 21 CFR 211.110(a)

Control procedures to monitor and validate performance

"Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."

About this data →

MHRA GMP Compliance 3 certificates

2025-03

2019-12

Compliant Non-Compliant

Certificate	Site	City / Postcode	Inspection Date	Status
UK MIA(IMP) 52811 Insp GMP/IMP 52811/17386-0042[I]	KINDEVA DRUG DELIVERY LIMITED	LOUGHBOROUGH LE11 5SF	2025-03-11	COMPLIANT
UK MIA 52811 Insp GMP/IMP 52811/17386-0042[H]	KINDEVA DRUG DELIVERY LIMITED	LOUGHBOROUGH LE11 5SF	2025-03-11	COMPLIANT
UK MIA 45438 Insp GMP 45438/17386-0030[H]	KINDEVA DRUG DELIVERY LIMITED	LOUGHBOROUGH LE11 5SF	2019-12-16	COMPLIANT