MassBiologics
Boston, MA
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
79.0
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
Quick Facts: MassBiologics
- Signal Score
- 79.0/100 (as of 2026-09-07)
- Quality Compliance
- 97.2/100
- Headquarters
- Boston, MA
- Modalities
- AAV, mRNA
- Active Programs
- Data pending
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About MassBiologics
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
97.2
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-12-18)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesAAV, mRNA
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity
58.0
Profile-based capacity assessment
MassBiologics FDA Inspection History
2025-12
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-12-18 |
MassBiologics
Boston, Massachusetts
Facility-linked
|
Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 07, 2026
MassBiologics FDA 483 Findings 1 observations · 2025-12-18 → 2025-12-18 ?
By subsystem
By severity
- 3 — Moderate: 1
- Repeat observations: 0
Most severe findings
-
Items to cover on annual reviews
"Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products and investigations conducted for each drug product."
Frequently Asked Questions About MassBiologics
How many FDA inspections does MassBiologics have on record?
CDMO Signal tracks 1 FDA inspection for MassBiologics, sourced from the FDA inspection database. See the full inspection history above.
Has MassBiologics received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for MassBiologics.
What is MassBiologics's CDMO Signal Score?
MassBiologics has a Signal Score of 79/100, based on quality, operations, financial stability, and capacity data.
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