Thermo Fisher Scientific / Patheon – Monza, Italy
Monza, Italy (site); Waltham, MA (corporate)
2 confirmed programs
· 2 sponsors
74.0
Signal Score
✓ FDA Inspections (6)
✓ Clinical Trials (2)
✓ SEC Filings (16)
✓ Press (20)
✓ EMA GMP (1)
✓ MHRA GMP (9)
Quick Facts: Thermo Fisher Scientific / Patheon – Monza, Italy
- Signal Score
- 74.0/100
- Quality Compliance
- 100.0/100 — Bonus: 3 consecutive NAI inspections
- Headquarters
- Monza, Italy (site); Waltham, MA (corporate)
- Modalities
- mRNA, LNP/Formulation, Sterile Fill-Finish, Prefilled Syringes, Cartridges, Lyophilized Vials, Sterile Liquids (SVP), Biologics
- Active Programs
- 2 confirmed from ClinicalTrials.gov across 2 sponsors
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Thermo Fisher Scientific / Patheon – Monza, Italy
Auto-created by AI matchmaker. Data verification pending.
Signal Score & Pillar Breakdown
Quality Compliance
100.0
Bonus: 3 consecutive NAI inspections
Source: FDA Data Dashboard
Bonus: 3 consecutive NAI inspections
FDA Inspections6 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2026-06-30)
EMA GMP Certificates1 on record
MHRA GMP Certificates9 on record
Bonus: 3 consecutive NAI inspections
Operations
60.0
2 active programs across 2 sponsors
Modalities: mRNA, Biologics, LNP/Formulation, Lyophilized Vials, Prefilled Syringes, Cartridges, Sterile Fill-Finish, Sterile Liquids (SVP)
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov
2 active programs across 2 sponsors · Modalities: mRNA, Biologics, LNP/Formulation, Lyophilized Vials, Prefilled Syringes, Cartridges, Sterile Fill-Finish, Sterile Liquids (SVP) · 2 programs in advanced phases (Phase 2/3)
Programs
2
Sponsors2
ModalitiesmRNA, LNP/Formulation, Sterile Fill-Finish, Prefilled Syringes, Cartridges, Lyophilized Vials, Sterile Liquids (SVP), Biologics
2 active programs across 2 sponsors
Modalities: mRNA, Biologics, LNP/Formulation, Lyophilized Vials, Prefilled Syringes, Cartridges, Sterile Fill-Finish, Sterile Liquids (SVP)
2 programs in advanced phases (Phase 2/3)
Source: ClinicalTrials.gov facility matching
Partnership Announcements (from press monitoring)
Source: ClinicalTrials.gov · Retrieved Aug 25, 2026
Financial Stability
60.0
Private company
Financial assessment: 60.0/100
Source: SEC EDGAR, press monitoring
16 SEC filings with industry mentions on record
SEC Filings16 with industry mentions
Private company
Financial assessment: 60.0/100
Capacity
60.0
Broad modality coverage (8 modalities)
Source: SEC EDGAR, press monitoring, company profiles
Profile-based capacity assessment
Recent Press20 articles
Broad modality coverage (8 modalities)
Thermo Fisher Scientific / Patheon – Monza, Italy FDA Inspection History
2026-06
2026-05
2025-09
2025-09
2025-07
2024-11
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-06-30 | Greenville, North Carolina | Vaccines and Allergenic Products | No | No Action Indicated (NAI) |
| 2026-05-07 | Allentown, Pennsylvania | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-26 | Greenville, North Carolina | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-26 | Cincinnati, Ohio | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-07-17 | High Point, North Carolina | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-11-20 | Saint Louis, Missouri | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Aug 25, 2026
Thermo Fisher Scientific / Patheon – Monza, Italy FDA 483 Findings 47 observations · 2025-07-17 → 2026-02-05 ?
By subsystem
By severity
- 3 — Moderate: 6
- 2 — Minor: 41
- Repeat observations: 0
Most severe findings
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been adequately established."
-
Written procedures - establish; returned dietary supplements
"You did not establish written procedures for when a returned dietary supplement is received, when a returned dietary supplement must be destroyed, or otherwise suitably disposed, when a returned dietary supplement may be salvaged, for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement and quality control personnel to approve a returned dietary supplement for reprocessing."
-
Lack of or inadequate procedures
"Procedures for corrective and preventive action have not been adequately established."
Thermo Fisher Scientific / Patheon – Monza, Italy EMA GMP Compliance 1 certificates
2025-11
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| CRN00GTCX/ASR12633 | Thermo Fisher Scientific Cork Limited | Ireland | 2025-11-07 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Aug 25, 2026
Thermo Fisher Scientific / Patheon – Monza, Italy MHRA GMP Compliance 9 certificates
2024-10
2024-10
2024-07
2024-07
2024-07
2021-03
2019-08
2019-01
2017-01
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 18693 Insp GMP/GDP/IMP 18693/11204-0018[H] | FISHER CLINICAL SERVICES UK LIMITED | HORSHAM RH12 4QD | 2024-10-08 | COMPLIANT |
| UK MIA(IMP) 18693 Insp GMP/GDP/IMP 18693/11204-0019[I] | FISHER CLINICAL SERVICES UK LIMITED | HORSHAM RH12 4QD | 2024-10-08 | COMPLIANT |
| UK MIA 17857 Insp GMP/IMP 17857/10036-0034[H] | PATHEON UK LIMITED | SWINDON SN3 5BZ | 2024-07-29 | COMPLIANT |
| UK MIA(IMP) 17857 Insp GMP/IMP 17857/10036-0034[I] | PATHEON UK LIMITED | SWINDON SN3 5BZ | 2024-07-29 | COMPLIANT |
| UK MIA(IMP) 32390 Insp GMP/IMP 32390/411870-0007[I] | THERMO ELECTRON LIMITED | BISHOP'S STORTFORD CM23 5RG | 2024-07-16 | COMPLIANT |
| UK MIA(IMP) 17857 Insp GMP/IMP 17857/14285-0011[I] | PATHEON UK LIMITED | ABINGDON OX14 4SD | 2021-03-24 | COMPLIANT |
| UK MIA(IMP) 32390 Insp IMP 32390/18853104-0001[I] | THERMO ELECTRON LIMITED | STEVENAGE SG1 2FX | 2019-08-29 | COMPLIANT |
| UK MIA(IMP) 18693 Insp GMP/GDP/IMP 18693/11485563-0003[I] | FISHER CLINICAL SERVICES LIMITED | CRAWLEY RH10 9NL | 2019-01-21 | COMPLIANT |
| UK GMP 20788 Insp GMP 20788/13917-0005[H] | PATHEON PHARMACEUTICALS INCORPORATED | 45237 | 2017-01-17 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Aug 25, 2026
Clinical Activity 2 studies
NCT02340936
Clinical Trial to Determinate Dose, Security and Efficacy or Lenalidomide...
PHASE1/PHASE2
Completed
NCT00982111
First-line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell...
PHASE3
Completed
Source: ClinicalTrials.gov · Retrieved Aug 25, 2026
Financial Intelligence
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
"Amounts expected to occur thereafter generally relate to contract manufacturing, clinical research and extended warranty service agreements, which typically have durations of
three
to
five years
."
Source: SEC EDGAR · Retrieved Aug 25, 2026
Recent News 20 articles
Thermo Fisher Unveils Integrated Platform to Advance Scalable Cell Therapy Manufacturing - Digital Health News
Thermo Fisher Unveils Integrated Platform to Advance Scalable Cell Therapy Manufacturing Digital Health News
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing - FinancialContent
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing FinancialContent
Thermo Fisher Scientific Introduces Gibco CTS DynaXS Single Use Bioreactor - Contract Pharma
Thermo Fisher Scientific Introduces Gibco CTS DynaXS Single Use Bioreactor Contract Pharma
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing - New Castle News
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing New Castle News
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing - The Joplin Globe
Thermo Fisher Scientific Unveils an Integrated Platform to Advance Scalable Cell Therapy Manufacturing The Joplin Globe
Thermo Fisher introduces integrated platform to advance scalable cell therapy manufacturing - BioSpectrum India
Thermo Fisher introduces integrated platform to advance scalable cell therapy manufacturing BioSpectrum India
Thermo Fisher Scientific launches applied Biosystems PowerFlex Thermal Cycler - Med-Tech Insights
Thermo Fisher Scientific launches applied Biosystems PowerFlex Thermal Cycler Med-Tech Insights
Thermo Fisher Scientific, SHL Medical Collaborate on Integrated Drug-Device Solutions - Medical Product Outsourcing
Thermo Fisher Scientific, SHL Medical Collaborate on Integrated Drug-Device Solutions Medical Product Outsourcing
Thermo Fisher Scientific Opens U.S. Flagship Bioprocess Design Center to Accelerate the Delivery of - PharmiWeb.com
Thermo Fisher Scientific Opens U.S. Flagship Bioprocess Design Center to Accelerate the Delivery of PharmiWeb.com
Thermo Fisher Scientific opens bioprocess design center with 4,000 sq. ft. of lab and training space - R&D World
Thermo Fisher Scientific opens bioprocess design center with 4,000 sq. ft. of lab and training space R&D World
Thermo Fisher opens Plainville design center amid $2B push for U.S. manufacturing - The Business Journals
Thermo Fisher opens Plainville design center amid $2B push for U.S. manufacturing The Business Journals
Thermo Fisher opens new facility for vaccine, gene therapy development - The Boston Globe
Thermo Fisher opens new facility for vaccine, gene therapy development The Boston Globe
Thermo Fisher Scientific Expands Plainville Facility With Flagship Bioprocess Design Center To Advance Biologics Development - BioPharma APAC
Thermo Fisher Scientific Expands Plainville Facility With Flagship Bioprocess Design Center To Advance Biologics Development BioPharma APAC
Thermo Fisher Scientific sells microbiology business for $1B to European private equity firm - Fierce Biotech
Thermo Fisher Scientific sells microbiology business for $1B to European private equity firm Fierce Biotech
Thermo Fisher CEO says onshoring push will bring a ‘tailwind’ for the Waltham company - The Business Journals
Thermo Fisher CEO says onshoring push will bring a ‘tailwind’ for the Waltham company The Business Journals
Healthcare Filtration Markets 2025-2035 with Focus on Biologics Manufacturing Featuring Alfa Laval, Asahi Kasei, Cobetter, Corning, Merck, Pall, Parker Hannifin, Sartorius, Thermo Fisher Scientific - Yahoo Finance
Healthcare Filtration Markets 2025-2035 with Focus on Biologics Manufacturing Featuring Alfa Laval, Asahi Kasei, Cobetter, Corning, Merck, Pall, Parker Hannifin, Sartorius, Thermo Fisher Scientific Yahoo Finance
Thermo Fisher Launches Automated Cell Therapy System - Technology Networks
Thermo Fisher Launches Automated Cell Therapy System Technology Networks
Thermo Fisher Launches Automated Cell Therapy System - Technology Networks
Thermo Fisher Launches Automated Cell Therapy System Technology Networks
How Investors May Respond To Thermo Fisher Scientific (TMO) Expanding Its Cell Therapy And Biologics Platforms - Sahm
How Investors May Respond To Thermo Fisher Scientific (TMO) Expanding Its Cell Therapy And Biologics Platforms Sahm
Thermo Fisher Scientific introduces the Gibco CTS Compleo Fill and Finish System - SelectScience
Thermo Fisher Scientific introduces the Gibco CTS Compleo Fill and Finish System Select Science
Frequently Asked Questions About Thermo Fisher Scientific / Patheon – Monza, Italy
How many FDA inspections does Thermo Fisher Scientific / Patheon – Monza, Italy have on record?
CDMO Signal tracks 6 FDA inspections for Thermo Fisher Scientific / Patheon – Monza, Italy, sourced from the FDA inspection database. See the full inspection history above.
Has Thermo Fisher Scientific / Patheon – Monza, Italy received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Thermo Fisher Scientific / Patheon – Monza, Italy.
Does Thermo Fisher Scientific / Patheon – Monza, Italy hold EMA or MHRA GMP certificates?
CDMO Signal tracks 1 EMA and 9 MHRA GMP certificates for Thermo Fisher Scientific / Patheon – Monza, Italy.
How many clinical programs is Thermo Fisher Scientific / Patheon – Monza, Italy linked to?
Thermo Fisher Scientific / Patheon – Monza, Italy is associated with 2 clinical trials in CDMO Signal's ClinicalTrials.gov-sourced data.
What is Thermo Fisher Scientific / Patheon – Monza, Italy's CDMO Signal Score?
Thermo Fisher Scientific / Patheon – Monza, Italy has a Signal Score of 74/100, based on quality, operations, financial stability, and capacity data.
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