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
Sponsors— no 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
By severity
- 2 — Minor: 1
- Repeat observations: 0
Most severe findings
-
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
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
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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