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01 4Sumitomo Chemical Co., Ltd.

02 5Sumitomo Chemical Company, Limited

03 1Sumitomo Dainippon Pharma Co., Ltd.

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PharmaCompass

01

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Anpachi-Gun

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-03-14

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02

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Oita

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-04-22

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03

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Kurashiki

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-07-15

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04

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Anpachi-Gun

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2016-09-23

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05

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Osaka

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2016-07-22

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06

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Anpachi-Gun

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-12-08

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07

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Pharma

City : Oita

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-02-17

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08

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Anpachi-Gun

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2009-04-09

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09

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Anpachi-Gun

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-06-18

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10

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Sumitomo Chemical

City : Oita

State :

Country/Area : JP

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-02-21

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