Grand River Aseptic Manufacturing
Grand Rapids, MI
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
66.6
Signal Score
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (5)
○ EMA GMP
○ MHRA GMP
Quick Facts: Grand River Aseptic Manufacturing
- Signal Score
- 66.6/100 (as of 2026-09-07)
- Quality Compliance
- 78.1/100
- Headquarters
- Grand Rapids, MI
- Modalities
- Biologics
- Active Programs
- Data pending
- 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
Scores are being republished.
Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance
78.1
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
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
60.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
53.0
Profile-based capacity assessment
Recent Press5 articles
Grand River Aseptic Manufacturing FDA Inspection History
2025-11
2025-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-11-04 |
Grand River Aseptic Manufacturing, Inc.
Grand Rapids, Michigan
Facility-linked
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-11-04 |
Grand River Aseptic Manufacturing Inc.
Caledonia, Michigan
Facility-linked
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 2026
Attribution not established
(1)
These records are excluded from this company’s established evidence
because their attribution is unresolved. This describes an evidence-linking
limitation, not an assessment of the underlying regulatory findings.
| Source | Establishment named by the regulator | Location | Identifier |
|---|---|---|---|
| FDA inspection | Division of Nuclear Medicine PET Radiopharmaceutical Production Program | Ann Arbor, Michigan | FDA/FEI=3010166888 |
Source records retained verbatim · attribution not established
Grand River Aseptic Manufacturing FDA 483 Findings 4 observations · 2025-11-04 → 2025-11-04 ?
By subsystem
By severity
- 4 — Serious: 1
- 2 — Minor: 3
- 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."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing."
-
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 2 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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