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01 3BAXALTA US INC.

02 7Baxalta Belgium Manufacturing SA

03 4Baxalta Manufacturing Sarl

04 10Baxalta US Inc.

05 8Baxalta US Incorporated

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PharmaCompass

01

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Los Angeles

State : California

Country/Area : U.S.A

Zip : 90039

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-05-31

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02

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Round Lake

State : Illinois

Country/Area : U.S.A

Zip : 60073

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-09-15

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03

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Round Lake

State : Illinois

Country/Area : U.S.A

Zip : 60073

District :

Center :

Project Area : Vaccines and Allergenic Products

District Decision : No Action Indicated

Inspection End Date : 2022-09-15

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04

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Thousand Oaks

State : California

Country/Area : U.S.A

Zip : 91320

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-04-07

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05

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Thousand Oaks

State : California

Country/Area : U.S.A

Zip : 91320

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2020-01-17

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06

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Round Lake

State : Illinois

Country/Area : U.S.A

Zip : 60073

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-09-25

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07

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Lessines

State :

Country/Area : Belgium

Zip :

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-05-31

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08

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Neuchatel

State :

Country/Area : Switzerland

Zip :

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-11-12

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09

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Los Angeles

State : California

Country/Area : U.S.A

Zip : 90039

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-11-02

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10

FDA Audited

USA
SCOPE Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
SCOPE Summit
Not Confirmed

Baxalta Pharmaceutical

City : Thousand Oaks

State : California

Country/Area : U.S.A

Zip : 91320

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-01-19

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