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01 2Chugai Pharma Manufacturing Co. Ltd. (CPMC)

02 2Chugai Pharma Manufacturing Co., Ltd.

03 1DSM Nutritional Products AG

04 7F. Hoffmann - La Roche Ltd.

05 8F. Hoffmann-La Roche AG

06 46Genentech, Inc.

07 5Hoffmann La Roche Inc

08 5Productos Roche S.A. de C. V.

09 10Roche Diagnostics GmbH

10 2Roche Ireland Limited

11 7Roche Molecular Systems, Inc.

12 3Roche Pharma AG

13 5Roche Singapore Technical Operations Pte. Ltd.

14 2Spark Therapeutics, Inc.

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PharmaCompass

01

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Chugai Pharmaceutical

City : Fujieda

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-07-04

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02

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Genentech

City : South San Francisco

State : California

Country/Area : U.S.A

Zip : 94080

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2025-04-21

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03

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Genentech

City : Oceanside

State : California

Country/Area : U.S.A

Zip : 92056

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-08-16

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04

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Genentech

City : South San Francisco

State : California

Country/Area : U.S.A

Zip : 94080

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-05-02

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05

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Genentech

City : Hillsboro

State : Oregon

Country/Area : U.S.A

Zip : 97124

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-04-19

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06

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Genentech

City : South San Francisco

State : California

Country/Area : U.S.A

Zip : 94080

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-03-20

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07

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Genentech

City : South San Francisco

State : California

Country/Area : U.S.A

Zip : 94080

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-03-12

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08

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

F. Hoffmann-La Roche

City : Basel Town

State :

Country/Area : Switzerland

Zip :

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-01-25

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09

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

F. Hoffmann-La Roche

City : Branchburg

State : New Jersey

Country/Area : U.S.A

Zip : 8876

District :

Center :

Project Area : Blood and Blood Products

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-12-08

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10

FDA Audited

USA
AMWC Asia-TDAC
Not Confirmed
arrow

FDA Audited

USA
arrow
AMWC Asia-TDAC
Not Confirmed

Chugai Pharmaceutical

City : Kita

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-10-27

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