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01 4Laboratoire Unither

02 6Unither Manufacturing LLC.

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PharmaCompass

01

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-06-21

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02

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-06-15

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03

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-05-22

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04

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-11-23

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05

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-01-19

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06

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-06-01

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07

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-03-01

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08

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-05-16

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09

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-09-19

blank

10

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-09-15

blank