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

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01 SCM Pharma Ltd (1)

02 SHIRE HUMAN GENETIC THERAPIES INC (11)

03 SHIRE LLC (7)

04 Shire (2)

05 Shire Human Genetic Therapies Inc (3)

06 Shire LLC (1)

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01 No Action Indicated (10)

02 Voluntary Action Indicated (15)

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01 2017-01-20 (1)

02 2017-01-05 (1)

03 2014-06-25 (1)

04 2014-01-30 (1)

05 2013-11-05 (1)

06 2013-08-05 (1)

07 2013-05-23 (1)

08 2012-09-28 (1)

09 2012-08-31 (1)

10 2012-04-02 (1)

11 2012-02-01 (1)

12 2012-01-11 (1)

13 2012-01-06 (1)

14 2011-06-02 (1)

15 2011-05-19 (1)

16 2011-02-16 (1)

17 2010-04-23 (2)

18 2010-04-22 (1)

19 2010-02-12 (1)

20 2010-01-07 (1)

21 2009-11-20 (3)

22 2009-05-03 (1)

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01 Belmont (2)

02 Cambridge (5)

03 Chesterbrook (2)

04 Florence (1)

05 Lexington (7)

06 North Reading (4)

07 Northumberland (1)

08 Wayne (3)

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01 GB (1)

02 US (24)

INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2017-01-20
Lexington
MA
US
02421-2101
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
No Action Indicated
2017-01-05
North Reading
MA
US
01864-2621
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2009-11-20
Cambridge
MA
US
02138-1100
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2011-05-19
Cambridge
MA
US
02138-1100
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2013-08-05
Cambridge
MA
US
02138-1100
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
No Action Indicated
2012-04-02
Lexington
MA
US
2421
NWE
CDER
Bioresearch Monitoring
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2010-01-07
Cambridge
MA
US
2139
NWE
CDER
Bioresearch Monitoring
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2012-02-01
Lexington
MA
US
2421
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2012-01-11
Cambridge
MA
US
2139
NWE
CDER
Drug Quality Assurance
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INSPECTIONS & REGISTRATIONS

URL Supplier Web Content
Voluntary Action Indicated
2012-01-06
North Reading
MA
US
1864
NWE
CDER
Drug Quality Assurance
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