Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
89.3
Signal Score
✓ FDA Inspections (7)
○ Clinical Trials
✓ SEC Filings (13)
✓ Press (19)
✓ EMA GMP (9)
✓ MHRA GMP (2)
Quick Facts: Charles River Laboratories
- Signal Score
- 89.3/100 (as of 2026-04-29)
- Quality Compliance
- 94.7/100
- Headquarters
- Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
- Modalities
- CAR-T, Cell Therapy, Gene Editing, Plasmid, AAV, Lentiviral, ADC
- Active Programs
- No ClinicalTrials.gov matches confirmed — 1 partnership announcement in press
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Charles River Laboratories
Acquired Cognate ($875M, 2021), Cobra Biologics, Vigene Biosciences.
Signal Score & Pillar Breakdown
Quality Compliance
94.7
FDA Inspections7 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2026-04-02)
EMA GMP Certificates9 on record
MHRA GMP Certificates2 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 1 partnership announcement found in press monitoring.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCAR-T, Cell Therapy, Gene Editing, Plasmid, AAV, Lentiviral, ADC
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.
Partnership Announcements (from press monitoring)
Financial Stability
81.0
Publicly traded — financial transparency
Strong industry presence in SEC filings (219 mentions)
Major facility investment disclosed in SEC filings
Multiple manufacturing risk factors in SEC filings
Source: SEC EDGAR, press monitoring
13 SEC filings with industry mentions on record
SEC Filings13 with industry mentions
Publicly traded — financial transparency
Strong industry presence in SEC filings (219 mentions)
Major facility investment disclosed in SEC filings
Multiple manufacturing risk factors in SEC filings
Capacity
88.0
Multi-site operations (5 manufacturing sites)
Broad modality coverage (7 modalities)
10 facility investment mentions in SEC filings
Sites: Newbury Park, CA, Memphis, TN, Mattawan, MI, Keele, UK, Rockville, MD
Source: SEC EDGAR, press monitoring, company profiles
5 manufacturing sites
StatusLimited
Multi-site operations (5 manufacturing sites)
Broad modality coverage (7 modalities)
10 facility investment mentions in SEC filings
Sites: Newbury Park, CA, Memphis, TN, Mattawan, MI, Keele, UK, Rockville, MD
Recent Press19 articles
Multi-site operations (5 manufacturing sites)
Broad modality coverage (7 modalities)
10 facility investment mentions in SEC filings
Charles River Laboratories FDA Inspection History
2026-04
2026-03
2026-01
2025-09
2025-09
2025-07
2025-05
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-02 | Wayne, Pennsylvania | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2026-03-27 | Charleston, South Carolina | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2026-01-20 | Malvern, Pennsylvania | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-17 | Shrewsbury, Massachusetts | Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-09 | Wilmington, Massachusetts | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-07-30 | Centerbrook, Connecticut | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-05-02 | Wilmington, Massachusetts | Vaccines and Allergenic Products | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
Charles River Laboratories FDA 483 Findings 12 observations · 2025-07-30 → 2026-03-27 ?
By subsystem
By severity
- 3 — Moderate: 3
- 2 — Minor: 9
- Repeat observations: 0
Most severe findings
-
Corrective action per predetermined plan
"You did not take corrective action that ensured affected product was not entered into commerce and the cause of the deviation was corrected."
-
Written record of investigation incomplete
"Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up."
-
Following/documenting laboratory controls
"Established laboratory control mechanisms are not followed."
Charles River Laboratories EMA GMP Compliance 9 certificates
2025-08
2025-08
2025-04
2025-04
2025-04
2022-07
2022-07
2022-07
2022-07
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| DE_NW_06_GMP_2025_0010 | Charles River Laboratories Germany GmbH | Germany | 2025-08-20 | COMPLIANT |
| DE_NW_03_GMP_2025_0098 | Charles River Laboratories Germany GmbH | Germany | 2025-08-20 | COMPLIANT |
| 35848/QCLab12286(H) | Charles River Laboratories Ireland Limited | Ireland | 2025-04-10 | COMPLIANT |
| 35848/QCLab12286(V) | Charles River Laboratories Ireland Limited | Ireland | 2025-04-10 | COMPLIANT |
| 35848/QCLab12286(IMP) | Charles River Laboratories Ireland Limited | Ireland | 2025-04-10 | COMPLIANT |
| 2022_HPF_FR_179 | Charles River Laboratories France C.R.L.F. | France | 2022-07-22 | COMPLIANT |
| 2022_HPF_FR_180_P_2025 | Charles River Laboratories France C.R.L.F. | France | 2022-07-22 | COMPLIANT |
| 2022_HPF_FR_180 | Charles River Laboratories France C.R.L.F. | France | 2022-07-22 | COMPLIANT |
| 2022_HPF_FR_179_P_2025 | Charles River Laboratories France C.R.L.F. | France | 2022-07-22 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 2026
Charles River Laboratories MHRA GMP Compliance 2 certificates
2019-11
2019-11
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 24616 Insp GMP/IMP 24616/25448-0034 [H] | CHARLES RIVER LABORATORIES EDINBURGH LIMITED | TRANENT EH33 2NE | 2019-11-21 | COMPLIANT |
| UK GMP 24616 Insp GMP/IMP 24616/25448-0034 [V] | CHARLES RIVER LABORATORIES EDINBURGH LIMITED | TRANENT EH33 2NE | 2019-11-21 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Jul 04, 2026
Financial Intelligence
"Planned Divestiture of CDMO and Cell Solutions Businesses
On February 25, 2026, Charles River Laboratories International, Inc."
"(the “Company”) announced that it has signed a definitive agreement to divest its contract development and manufacturing products and services (“CDMO”) and Cell Solutions businesses to GI Partners, primarily for future, contingent performance-based payments."
"The CDMO business provides services related to the production of advanced therapies for gene-modified cell therapies, as well as gene therapies including viral vectors and plasmid DNA; and the Cell Solutions business provides human-derived cellular materials used in the development and production of cell therapies."
"Our client base includes major global pharmaceutical companies, many biotechnology companies;
agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies
around the world."
"We have extensive expertise in the discovery of clinical candidates and in the design, execution and reporting of safety assessment studies for numerous types of therapeutic modalities, including cell and gene therapies, small and large molecule pharmaceuticals, industrial and agricultural chemicals, vaccines, consumer products, veterinary medicines, biocides and medical devices."
"Biologics Solutions is comprised of both our Biologics Testing Solutions business, which provides specialized testing of biologics frequently outsourced by global pharmaceutical and biotechnology companies, and our contract development and manufacturing products and services (“CDMO”) business, which provides comprehensive contract development and manufacturing solutions for cell and gene therapies."
"The Company’s Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"The decrease in intangible assets for the nine months ended September 27, 2025 related primarily to the accelerated amortization of certain CDMO client relationships in the Biologics Solutions reporting unit, normal amortization over the useful lives, and a divestiture of a site in the DSA reportable segment."
"Our client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world."
"The Company’s Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"The decrease in intangible assets for the six months ended June 28, 2025 related primarily to the accelerated amortization of certain CDMO client relationships in the Biologics Solutions reporting unit, normal amortization over the useful lives, and a divestiture of a site in the DSA reportable segment."
"Our client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world."
"The Company’s Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"The decrease in intangible assets for the three months ended March 29, 2025 related primarily to the accelerated amortization of certain CDMO client relationships in the Biologics Solutions reporting unit, normal amortization over the useful lives, and a divestiture of a site in the DSA reportable segment."
"Our client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world."
"Our client base includes major global pharmaceutical companies, many biotechnology companies;
agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies
around the world."
"We have extensive expertise in the discovery of clinical candidates and in the design, execution and reporting of safety assessment studies for numerous types of therapeutic modalities, including cell and gene therapies, small and large molecule pharmaceuticals, industrial and agricultural chemicals, vaccines, consumer products, veterinary medicines, biocides and medical devices."
"Biologics Solutions is comprised of both our Biologics Testing Solutions business, which provides specialized testing of biologics frequently outsourced by global pharmaceutical and biotechnology companies, and our contract development and manufacturing products and services (“CDMO”) business, which provides comprehensive contract development and manufacturing solutions for cell and gene therapies."
"The Company’s Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"Our client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world."
"Our Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"Attorney’s Office for the Southern District of Florida that a Cambodian non-human primate supplier and two Cambodian officials had been criminally charged in connection with illegally importing non-human primates into the United States; client demand, particularly future demand for drug discovery and development products and services, including the outsourcing of these services; our expectations with respect to our ability to meet financial targets; our expectations regarding stock repurchases, "
"The Company’s Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
(non-animal) lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"Our client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world."
"Attorney’s Office for the Southern District of Florida that a Cambodian non-human primate supplier and two Cambodian officials had been criminally charged in connection with illegally importing non-human primates into the United States; client demand, particularly future demand for drug discovery and development products and services, including the outsourcing of these services; our expectations with respect to our ability to meet financial targets; our expectations regarding stock repurchases, "
"The Company’s Manufacturing reportable segment includes Microbial Solutions, which provides
in vitro
(non-animal) lot-release testing products, microbial detection products, and species identification services and Biologics Solutions (Biologics), which performs specialized testing of biologics (Biologics Testing Solutions) as well as contract development and manufacturing products and services (CDMO)."
"Our client base includes major global pharmaceutical companies, many biotechnology companies; agricultural and industrial chemical, life science, veterinary medicine, medical device, diagnostic and consumer product companies; contract research and contract manufacturing organizations; and other commercial entities, as well as leading hospitals, academic institutions, and government agencies around the world."
Source: SEC EDGAR · Retrieved Jul 04, 2026
Recent News 19 articles
Charles River Laboratories Stock: Q1 2026 Earnings Release Scheduled for April 30 - AD HOC NEWS
Charles River Laboratories Stock: Q1 2026 Earnings Release Scheduled for April 30 AD HOC NEWS
Charles River Laboratories stock (US1591881009): Why Google Discover changes matter more now - AD HOC NEWS
Charles River Laboratories stock (US1591881009): Why Google Discover changes matter more now AD HOC NEWS
Charles River Laboratories stock (US1591881009): Is its drug discovery dominance strong enough to un - AD HOC NEWS
Charles River Laboratories stock (US1591881009): Is its drug discovery dominance strong enough to un AD HOC NEWS
A Look Back at Drug Development Inputs & Services Stocks’ Q4 Earnings: Charles River Laboratories (NYSE:CRL) Vs The Rest Of The Pack - TradingView
A Look Back at Drug Development Inputs & Services Stocks’ Q4 Earnings: Charles River Laboratories (NYSE:CRL) Vs The Rest Of The Pack TradingView
A Review of Q4 Earnings for Drug Development Inputs & Services Stocks: Comparing Charles River Laboratories (NYSE:CRL) with Its Peers - Bitget
A Review of Q4 Earnings for Drug Development Inputs & Services Stocks: Comparing Charles River Laboratories (NYSE:CRL) with Its Peers Bitget
A Look Back at Drug Development Inputs & Services Stocks’ Q4 Earnings: Charles River Laboratories (NYSE:CRL) Vs The Rest Of The Pack - StockStory
A Look Back at Drug Development Inputs & Services Stocks’ Q4 Earnings: Charles River Laboratories (NYSE:CRL) Vs The Rest Of The Pack StockStory
A Review of Q4 Earnings for Drug Development Inputs & Services Stocks: Comparing Charles River Laboratories (NYSE:CRL) with Its Peers - Bitget
A Review of Q4 Earnings for Drug Development Inputs & Services Stocks: Comparing Charles River Laboratories (NYSE:CRL) with Its Peers Bitget
Charles River Laboratories parts ways with its CDMO business - European Pharmaceutical Review
Charles River Laboratories parts ways with its CDMO business European Pharmaceutical Review
Charles River Laboratories to divest a number of assets to IQVIA and GI Partners - Business Weekly
Charles River Laboratories to divest a number of assets to IQVIA and GI Partners Business Weekly
Charles River Laboratories Provides Update on Planned Divestitures - Business Wire
Charles River Laboratories Provides Update on Planned Divestitures Business Wire
Charles River Laboratories to divest CDMO, Cell Solutions, and European assets - Investing.com
Charles River Laboratories to divest CDMO, Cell Solutions, and European assets Investing.com
Charles River Laboratories to divest CDMO, Cell Solutions and European discovery assets; updates 2026 guidance - TradingView
Charles River Laboratories to divest CDMO, Cell Solutions and European discovery assets; updates 2026 guidance TradingView
Charles River Laboratories to divest CDMO, Cell Solutions, and European assets - Investing.com
Charles River Laboratories to divest CDMO, Cell Solutions, and European assets Investing.com
Charles River Laboratories to divest CDMO, Cell Solutions, and European assets - Investing.com Australia
Charles River Laboratories to divest CDMO, Cell Solutions, and European assets Investing.com Australia
Charles River Laboratories: Why This Quiet Giant Suddenly Matters to You - AD HOC NEWS
Charles River Laboratories: Why This Quiet Giant Suddenly Matters to You AD HOC NEWS
Charles River Laboratories Announces Fourth-Quarter and Full-Year 2025 Results and Provides 2026 Guidance - Business Wire
Charles River Laboratories Announces Fourth-Quarter and Full-Year 2025 Results and Provides 2026 Guidance Business Wire
Analysts Are Bullish On Charles River Laboratories (CRL) Prospects - Finviz
Analysts Are Bullish On Charles River Laboratories (CRL) Prospects Finviz
Analysts Are Bullish On Charles River Laboratories (CRL) Prospects - Insider Monkey
Analysts Are Bullish On Charles River Laboratories (CRL) Prospects Insider Monkey
Analysts Are Bullish On Charles River Laboratories (CRL) Prospects - Bitget
Analysts Are Bullish On Charles River Laboratories (CRL) Prospects Bitget
Frequently Asked Questions About Charles River Laboratories
How many FDA inspections does Charles River Laboratories have on record?
CDMO Signal tracks 7 FDA inspections for Charles River Laboratories, sourced from the FDA inspection database. See the full inspection history above.
Has Charles River Laboratories received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Charles River Laboratories.
Does Charles River Laboratories hold EMA or MHRA GMP certificates?
CDMO Signal tracks 9 EMA and 2 MHRA GMP certificates for Charles River Laboratories.
What is Charles River Laboratories's CDMO Signal Score?
Charles River Laboratories has a Signal Score of 89/100, based on quality, operations, financial stability, and capacity data.
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