Shire Human Genetic Therapies Inc | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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SHIRE HUMAN GENETIC THERAPIES INC
FDA

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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SHIRE HUMAN GENETIC THERAPIES INC

VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 2 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
2 News #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

2 FDF Dossiers
2 FDA Orange Book

INSPECTIONS & REGISTRATIONS

7 FDA

7 FDA

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filter Legal Name Reset all filters

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01 7Shire Human Genetic Therapies Inc

filter District Decision Reset all filters

7 All

01 3No Action Indicated

02 4Voluntary Action Indicated

filter Inspection End Date Reset all filters

7 All

01 12018-02-01

02 12015-09-04

03 12013-08-05

04 12011-06-02

05 12011-05-19

06 22009-11-20

filter City Reset all filters

7 All

01 7Cambridge

filter Country/Area Reset all filters

7 All

01 7U.S.A

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01

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-02-01

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-02-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2015-09-04

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-09-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-08-05

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-08-05

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2011-06-02

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2011-06-02

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-05-19

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-11-20

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-11-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

IPPE

Not Confirmed

FDA Audited

USA

IPPE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2009-11-20

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : Massachusetts

Country/Area : U.S.A

Zip : 2138

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-11-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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