Grand River Aseptic Manufacturing
Grand Rapids, MI
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
67.0
Signal Score
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
✓ Press (5)
○ EMA GMP
○ MHRA GMP
Quick Facts: Grand River Aseptic Manufacturing
- Signal Score
- 67.0/100 (as of 2026-04-29)
- Quality Compliance
- 76.8/100 — 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
76.8
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
Grand River Aseptic Manufacturing 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 Jul 04, 2026
Grand River Aseptic Manufacturing FDA 483 Findings 12 observations · 2025-08-19 → 2025-11-04 ?
By subsystem
By severity
- 4 — Serious: 1
- 3 — Moderate: 1
- 2 — Minor: 10
- Repeat observations: 0
Most severe findings
-
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."
-
Allergen preventive controls - Identify (Written)
"You did not identify an allergen preventive control for a hazard when one was needed."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing."
Recent News 5 articles
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
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
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
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
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
Frequently Asked Questions About Grand River Aseptic Manufacturing
How many FDA inspections does Grand River Aseptic Manufacturing have on record?
CDMO Signal tracks 3 FDA inspections for Grand River Aseptic Manufacturing, sourced from the FDA inspection database. See the full inspection history above.
Has Grand River Aseptic Manufacturing received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Grand River Aseptic Manufacturing.
What is Grand River Aseptic Manufacturing's CDMO Signal Score?
Grand River Aseptic Manufacturing has a Signal Score of 67/100, based on quality, operations, financial stability, and capacity data.
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