Grand River Aseptic Manufacturing

Grand Rapids, MI
Biologics
Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29
66.6
Signal Score
✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ✓ Press (5) ○ EMA GMP ○ MHRA GMP

Quick Facts: Grand River Aseptic Manufacturing

Signal Score
66.6/100 (as of 2026-04-29)
Quality Compliance
75.9/100 — OAI classification at Ann Arbor (2025-09-17) — CRITICAL
Headquarters
Grand Rapids, MI
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 Grand River Aseptic Manufacturing

Pure-play CDMO.

Signal Score & Pillar Breakdown

Quality Compliance 75.9
OAI classification at Ann Arbor (2025-09-17) — CRITICAL
Source: FDA Data Dashboard
OAI classification at Ann Arbor (2025-09-17) — CRITICAL
FDA Inspections3 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-11-04)
OAI classification at Ann Arbor (2025-09-17) — CRITICAL
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 57.0
Facility expansion news detected
Sites: Grand Rapids, MI
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press5 articles
Facility expansion news detected

FDA Inspection History

2025-11
2025-11
2025-09
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)
2025-09-17 Ann Arbor, Michigan Drug Quality Assurance Yes Official Action Indicated (OAI)
Source: FDA Data Dashboard · Retrieved May 20, 2026

FDA 483 Findings 12 observations · 2025-08-19 → 2025-11-04 ?

By subsystem

  • Documentation & Records 5 (41.7%)
  • Other 3 (25.0%)
  • Equipment & Facilities 2 (16.7%)
  • Environmental Monitoring 1 (8.3%)
  • CAPA 1 (8.3%)

By severity

  • 4 — Serious: 1
  • 3 — Moderate: 1
  • 2 — Minor: 10
  • Repeat observations: 0

Most severe findings

  • Serious (4) Environmental Monitoring 2025-11-04 21 CFR 211.113(b)
    Validation lacking for sterile drug products

    "Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process."

  • Moderate (3) CAPA 2025-10-07 21 CFR 117.135(a)(1)
    Allergen preventive controls - Identify (Written)

    "You did not identify an allergen preventive control for a hazard when one was needed."

  • Minor (2) Documentation & Records 2025-11-04 21 CFR 211.22(d)
    Procedures not in writing, fully followed

    "The responsibilities and procedures applicable to the quality control unit are not in writing."

About this data →

Recent News 5 articles

facility_expansion 2026-04-27
Grand River Aseptic’s $100M investment in new facility will add capacity, grow workforce to 1,000 - Crain's Grand Rapids
Grand River Aseptic’s $100M investment in new facility will add capacity, grow workforce to 1,000  Crain's Grand Rapids Business
Source →
capacity 2026-04-16
Grand River Aseptic Manufacturing invests $100M in sterile fill-finish capacity - megaproject.com
Grand River Aseptic Manufacturing invests $100M in sterile fill-finish capacity  megaproject.com
Source →
general 2026-04-14
Grand River Aseptic Manufacturing Announces $100 Million Investment In Sterile Manufacturing Capabilities - Bioprocess Online
Grand River Aseptic Manufacturing Announces $100 Million Investment In Sterile Manufacturing Capabilities  Bioprocess Online
Source →
general 2026-04-14
Grand River Aseptic Manufacturing Announces $100 Million Investment in Sterile Manufacturing Capabilities - Yahoo Finance
Grand River Aseptic Manufacturing Announces $100 Million Investment in Sterile Manufacturing Capabilities  Yahoo Finance
Source →
general 2026-04-14
Grand River Aseptic Manufacturing Announces $100 Million Investment in Sterile Manufacturing Capabilities - The Manila Times
Grand River Aseptic Manufacturing Announces $100 Million Investment in Sterile Manufacturing Capabilities  The Manila Times
Source →
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