Grand River Aseptic Manufacturing

Grand Rapids, MI
Biologics
Program data pending ClinicalTrials.gov matching · Last scored 2026-03-15
56.5
Signal Score
✓ FDA Inspections (2) ○ Clinical Trials ○ SEC Filings ✓ Press (1)

Quick Facts: Grand River Aseptic Manufacturing

Signal Score
56.5/100 (as of 2026-03-15)
Quality Compliance
Assessment pending
Headquarters
Grand Rapids, MI
Modalities
Biologics
Active CGT Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By
CDMO Signal — independent CGT manufacturing intelligence platform

Signal Score & Pillar Breakdown

Quality Compliance —
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
FDA Inspections2 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
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 60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 60.0/100
Capacity 53.0
1 CGT manufacturing site: Grand Rapids, MI
Modalities: Biologics
Capacity assessment: 53.0/100
Sites: Grand Rapids, MI
Source: SEC EDGAR, press monitoring, company profiles
1 CGT manufacturing site
Recent Press1 articles
1 CGT manufacturing site: Grand Rapids, MI
Modalities: Biologics
Capacity assessment: 53.0/100

FDA Inspection History

2025-11
2025-11
NAI VAI OAI
Date Site Type Observations Classification
2025-11-04 Grand Rapids, Michigan Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2025-11-04 Caledonia, Michigan Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Mar 20, 2026

Recent News 1 articles

capacity 2026-02-23
Inside the sterile fill capacity crunch - Fierce Pharma
Inside the sterile fill capacity crunch  Fierce Pharma
Source →
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