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Details of Shire Plc's U.S. FDA Inspections. Original Data: FDA Inspection Database

SHIRE PLC
SHIRE LLC
SCM Pharma
SHIRE DEVELOPMENT
SHIRE VIROPHARM INC
SHIRE ORPHAN THERAP
New River Pharmaceuticals
SHIRE HUMAN GENETIC THERAPIES INC
FDA

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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xyz-pharma-m-2024-10-07

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Evonik

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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xyz-pharma-m-2024-10-07

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SHIRE PLC

VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 414 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
414 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

2 All APIs, 2 JDMF

2 All APIs
2 JDMF

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

142 FDF Dossiers, 50 FDA Orange Book, 92 Europe

142 FDF Dossiers
50 FDA Orange Book
92 Europe

INSPECTIONS & REGISTRATIONS

25 FDA, 7 EDQM

25 FDA
7 EDQM

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FILTER :

filter Legal Name Reset all filters

25 All

01 1SCM Pharma Ltd

02 11SHIRE HUMAN GENETIC THERAPIES INC

03 7SHIRE LLC

04 2Shire

05 3Shire Human Genetic Therapies Inc

06 1Shire LLC

filter District Decision Reset all filters

25 All

01 10No Action Indicated

02 15Voluntary Action Indicated

filter Inspection End Date Reset all filters

25 All

01 12017-01-20

02 12017-01-05

03 12014-06-25

04 12014-01-30

05 12013-11-05

06 12013-08-05

07 12013-05-23

08 12012-09-28

09 12012-08-31

10 12012-04-02

11 12012-02-01

12 12012-01-11

13 12012-01-06

14 12011-06-02

15 12011-05-19

16 12011-02-16

17 22010-04-23

18 12010-04-22

19 12010-02-12

20 12010-01-07

21 32009-11-20

22 12009-05-03

filter City Reset all filters

25 All

01 2Belmont

02 5Cambridge

03 2Chesterbrook

04 1Florence

05 7Lexington

06 4North Reading

07 1Northumberland

08 3Wayne

filter Country/Area Reset all filters

25 All

01 1GB

02 24US

FDA
EDQM

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2010-01-07

SHIRE HUMAN GENETIC THERAPIES INC

City : Cambridge

State : MA

Country/Area : US

Zip : 2139

District : NWE

Center : CDER

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-01-07

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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
#PharmaFlow

06

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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

07

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2017-01-20

City : Lexington

State : MA

Country/Area : US

Zip : 02421-2101

District : NWE

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-01-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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