Evonik Health Care

Birmingham, AL · Vancouver, BC
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
81.4
Signal Score
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ✓ Press (2) ○ EMA GMP ✓ MHRA GMP (2)

Quick Facts: Evonik Health Care

Signal Score
81.4/100 (as of 2026-04-29)
Quality Compliance
99.6/100
Headquarters
Birmingham, AL · Vancouver, BC
Modalities
mRNA, 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 Evonik Health Care

LNP formulation and drug delivery CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 99.6
FDA Inspections2 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-09-11)
MHRA GMP Certificates2 on record
Operations
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs no verified data
Sponsorsno verified data
ModalitiesmRNA, Biologics
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 68.0
Parent company: Evonik Industries (EVK.DE)
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Evonik Industries (EVK.DE)
Financial assessment: 68.0/100
Capacity 63.0
2 manufacturing sites
Sites: Birmingham, AL, Vancouver, BC
Source: SEC EDGAR, press monitoring, company profiles
2 manufacturing sites
Recent Press2 articles
2 manufacturing sites

Evonik Health Care FDA Inspection History

2025-09
2024-12
NAI VAI OAI
Date Site Type Observations Classification
2025-09-11 Lafayette, Indiana Drug Quality Assurance No No Action Indicated (NAI)
2024-12-10 Birmingham, Alabama Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Jul 04, 2026

Evonik Health Care FDA 483 Findings 1 observations · 2025-11-07 → 2025-11-07 ?

By subsystem

  • Other 1 (100.0%)

By severity

  • 2 — Minor: 1
  • Repeat observations: 0

Most severe findings

  • Minor (2) Other 2025-11-07 21 CFR 117.35(c)
    Pest control

    "You did not exclude pests from your food plant to protect against contamination of food."

Evonik Health Care MHRA GMP Compliance 2 certificates

2016-05
2016-05
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK GMP 36752 Insp GMP 36752/7750465-0002 [H] EVONIK CORPORATION 35211 2016-05-09 COMPLIANT
UK GMP 36752 Insp GMP 36752/7750465-0002 [V] EVONIK CORPORATION 35211 2016-05-09 COMPLIANT
Source: MHRA GMDP Database · Retrieved Jul 04, 2026

Recent News 2 articles

capacity 2026-04-24
Evonik Boosts Biotechnology Capacity for Drug Substance Production Through New Investment in Slovakia - ChemAnalyst
Evonik Boosts Biotechnology Capacity for Drug Substance Production Through New Investment in Slovakia  ChemAnalyst
general 2026-04-22
Evonik expands biotechnology capabilities in Slovakia - The Chemical Engineer
Evonik expands biotechnology capabilities in Slovakia  The Chemical Engineer

Frequently Asked Questions About Evonik Health Care

How many FDA inspections does Evonik Health Care have on record?
CDMO Signal tracks 2 FDA inspections for Evonik Health Care, sourced from the FDA inspection database. See the full inspection history above.
Has Evonik Health Care received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Evonik Health Care.
Does Evonik Health Care hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 MHRA GMP certificates for Evonik Health Care.
What is Evonik Health Care's CDMO Signal Score?
Evonik Health Care has a Signal Score of 81/100, based on quality, operations, financial stability, and capacity data.
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