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01 2Acerta Pharma, LLC

02 4Alexion Pharma International Operations Unlimited Co.

03 4Alexion Pharma LLC

04 25Alexion Pharmaceuticals, Inc.

05 1Astra Zeneca Pharma

06 1Astra Zeneca Via Tata Consultancy Services

07 14AstraZeneca AB

08 5AstraZeneca Dunkerque Production (AZDP)

09 1AstraZeneca GmbH

10 5AstraZeneca LP

11 6AstraZeneca Nijmegen B.V.

12 52AstraZeneca Pharmaceuticals LP

13 10AstraZeneca Pharmaceuticals, LP

14 6AstraZeneca UK Ltd.

15 8AstraZeneca, PLC

16 8IPR Pharmaceuticals, Inc.

17 4MedImmune Vaccines, Inc

18 3MedImmune, LLC

19 1Omthera Pharmaceuticals

20 1Portola Pharmaceuticals, Inc.

21 1Synageva Biopharma

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PharmaCompass

01

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Philadelphia

State : Pennsylvania

Country/Area : U.S.A

Zip : 19114

District :

Center :

Project Area : Vaccines and Allergenic Products

District Decision : No Action Indicated

Inspection End Date : 2025-06-24

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02

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Canovanas

State : Puerto Rico

Country/Area : U.S.A

Zip : 729

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2025-05-12

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03

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

Alexion Pharmaceuticals

City : Boston

State : Massachusetts

Country/Area : U.S.A

Zip : 2210

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-03-07

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04

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

Alexion Pharmaceuticals

City : Boston

State : Massachusetts

Country/Area : U.S.A

Zip : 2210

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-11-07

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05

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Gaithersburg

State : Maryland

Country/Area : U.S.A

Zip : 20878

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-10-25

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06

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Wilmington

State : Delaware

Country/Area : U.S.A

Zip : 19897

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-10-04

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07

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Gaithersburg

State : Maryland

Country/Area : U.S.A

Zip : 20878

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-05-31

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08

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

Alexion Pharmaceuticals

City : Athlone

State :

Country/Area : Ireland

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-05-17

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09

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Nijmegen

State :

Country/Area : Netherlands

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-04-10

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10

FDA Audited

USA
PEGS Boston Summit
Not Confirmed
arrow

FDA Audited

USA
arrow
PEGS Boston Summit
Not Confirmed

AstraZeneca

City : Gaithersburg

State : Maryland

Country/Area : U.S.A

Zip : 20878

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-01-22

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