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

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SHIRE HUMAN GENETIC THERAPIES INC
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SHIRE HUMAN GENETIC THERAPIES INC

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 2 NEWS #PharmaBuzz

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FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

2 FDF Dossiers
2 FDA Orange Book

INSPECTIONS & REGISTRATIONS

14 FDA

14 FDA

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filter Legal Name Reset all filters

14 All

01 11SHIRE HUMAN GENETIC THERAPIES INC

02 3Shire Human Genetic Therapies Inc

filter District Decision Reset all filters

14 All

01 4No Action Indicated

02 10Voluntary Action Indicated

filter Inspection End Date Reset all filters

14 All

01 12014-01-30

02 12013-08-05

03 12013-05-23

04 12012-08-31

05 12012-04-02

06 12012-02-01

07 12012-01-11

08 12012-01-06

09 12011-06-02

10 12011-05-19

11 12011-02-16

12 12010-01-07

13 22009-11-20

filter City Reset all filters

14 All

01 2Belmont

02 5Cambridge

03 4Lexington

04 3North Reading

filter Country/Area Reset all filters

14 All

01 14US

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01

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2014-01-30

SHIRE HUMAN GENETIC THERAPIES INC

City : North Reading

State : MA

Country/Area : US

Zip : 1864

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-01-30

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02

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : MA

Country/Area : US

Zip : 02138-1100

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-08-05

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Data Compilation
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03

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2013-05-23

SHIRE HUMAN GENETIC THERAPIES INC

City : Lexington

State : MA

Country/Area : US

Zip : 2421

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-05-23

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04

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2012-08-31

SHIRE HUMAN GENETIC THERAPIES INC

City : Lexington

State : MA

Country/Area : US

Zip : 2421

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-08-31

Product
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Stock Recap
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Data Compilation
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05

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2012-04-02

SHIRE HUMAN GENETIC THERAPIES INC

City : Lexington

State : MA

Country/Area : US

Zip : 2421

District : NWE

Center : CDER

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2012-04-02

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06

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2012-02-01

SHIRE HUMAN GENETIC THERAPIES INC

City : Lexington

State : MA

Country/Area : US

Zip : 2421

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-02-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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07

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2012-01-11

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : MA

Country/Area : US

Zip : 2139

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-01-11

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : 2012-01-06

SHIRE HUMAN GENETIC THERAPIES INC

City : North Reading

State : MA

Country/Area : US

Zip : 1864

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-01-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : Belmont

State : MA

Country/Area : US

Zip : 2478

District : NWE

Center : CDER

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

10

FDA Audited

USA

BioAsia

Not Confirmed

FDA Audited

USA

BioAsia

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 : MA

Country/Area : US

Zip : 02138-1100

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-05-19

Product
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Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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