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01 1Amgen Manufacturing Limited

02 1Amgen, Inc.

03 3Horizon Pharmaceuticals, Inc.

04 2MUSTAFA NEVZAT ILAC SANAYI A S

05 2Mustafa Nevzat Ilac Sanayii, A.S.

06 1Mustafa Ozguroglu

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PharmaCompass

01

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Amgen Inc

City : Thousand Oaks

State : CA

Country/Area : US

Zip : 91320-1730

District : LOS

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-04-19

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02

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Amgen Inc

City : Juncos

State : PR

Country/Area : US

Zip : 00777

District : SJN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-10

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03

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Mustafa Nevzat Ilac Sanayi A S

City : Bahcelievler

State :

Country/Area : TR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-06-01

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04

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Mustafa Nevzat Ilac Sanayi A S

City : Istanbul

State :

Country/Area : TR

Zip :

District : ORA

Center : CDER

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-05-14

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05

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Horizon Therapeutics

City : Riviera Beach

State : FL

Country/Area : US

Zip : 33404-3452

District : FLA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-09-26

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06

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Mustafa Nevzat Ilac Sanayi A S

City : Bahcelievler

State :

Country/Area : TR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2012-05-03

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07

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Horizon Therapeutics

City : Riviera Beach

State : FL

Country/Area : US

Zip : 33404-3452

District : FLA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-05-17

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08

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Mustafa Nevzat Ilac Sanayi A S

City : CA?ayirova

State :

Country/Area : TR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-04-19

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09

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Mustafa Nevzat Ilac Sanayi A S

City : CA?ayirova

State :

Country/Area : TR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-06-03

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10

FDA Audited

USA
Pharma, Lab & Chemical Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

Horizon Therapeutics

City : Riviera Beach

State : FL

Country/Area : US

Zip : 33404-3452

District : FLA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-07-15

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