AstraZeneca
FDA Inspections Database

AstraZeneca

FDA Inspections Database

U.S. FDA inspection classifications and citation records from the official FDA inspection database.

NAI · No Action IndicatedVAI · Voluntary Action Indicated United States
  • Total Records 77
  • Latest Inspection 2026-01-14
  • Data Source U.S. FDA
  • Last Updated 2026-04-02
All
All
77
View records
NAI
No Action Indicated
46
View records
VAI
Voluntary Action Indicated
31
View records
OAI
Official Action Indicated
0
No records
Company Overview

Company

AstraZeneca

Country

United Kingdom

Company Snapshot

AstraZeneca

2 Kingdom Street, Paddington, London W2 6BD

United Kingdom

www.astrazeneca.com/ Russell.Gantt@astrazeneca.com View on Map
FDA Inspections Timeline (77 records)
2026
14 Jan
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2026-01-14

FMD Date

2026-04-02

Fiscal Year

2026

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2026
Citations: No

2025
13 Nov
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Compliance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2025-11-13

FMD Date

-

Fiscal Year

2026

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2026
Citations: No

2025
13 Nov
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Postmarket Assurance: Devices

Product Type

Devices

Posted Citations

No

Inspection End Date

2025-11-13

FMD Date

-

Fiscal Year

2026

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2026
Citations: No

2025
24 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2025-06-24

FMD Date

2025-08-25

Fiscal Year

2025

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2025
Citations: No

2024
25 Oct
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2024-10-25

FMD Date

2025-01-16

Fiscal Year

2025

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2025
Citations: No

2024
04 Oct
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2024-10-04

FMD Date

2025-03-12

Fiscal Year

2025

State

Delaware

Wilmington, United States

Additional Details

Sponsor, Contract Research Organization

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2025
Citations: No

2024
31 May
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2024-05-31

FMD Date

2024-08-15

Fiscal Year

2024

State

Maryland

Gaithersburg, United States

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2024
Citations: Yes

2024
22 Jan
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2024-01-22

FMD Date

2024-03-07

Fiscal Year

2024

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2024
Citations: No

2023
20 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2023-09-20

FMD Date

2024-04-04

Fiscal Year

2023

State

Delaware

Wilmington, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2023
Citations: No

2023
19 Sep
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2023-09-19

FMD Date

2023-12-15

Fiscal Year

2023

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2023
Citations: Yes

2023
18 Jul
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2023-07-18

FMD Date

2023-10-19

Fiscal Year

2023

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2023
Citations: No

2023
19 Jan
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2023-01-19

FMD Date

2023-03-15

Fiscal Year

2023

State

Maryland

Frederick, United States

Location

Frederick, Maryland, United States

Inspection Info

Fiscal Year: 2023
Citations: No

2022
01 Dec
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2022-12-01

FMD Date

-

Fiscal Year

2023

State

Sodertalje, Sweden

Additional Details

Mutual Recognition Agreement (MRA)

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2023
Citations: No

2022
01 Dec
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2022-12-01

FMD Date

-

Fiscal Year

2023

State

Sodertalje, Sweden

Additional Details

Mutual Recognition Agreement (MRA)

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2023
Citations: No

2022
22 Jul
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2022-07-22

FMD Date

2022-10-20

Fiscal Year

2022

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2022
Citations: Yes

2021
25 Oct
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2021-10-25

FMD Date

2021-11-17

Fiscal Year

2022

State

California

Redwood City, United States

Location

Redwood City, California, United States

Inspection Info

Fiscal Year: 2022
Citations: No

2021
30 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2021-09-30

FMD Date

2021-12-21

Fiscal Year

2021

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2021
Citations: No

2021
26 Feb
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2021-02-26

FMD Date

2021-07-02

Fiscal Year

2021

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2021
Citations: No

2020
27 Oct
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2020-10-27

FMD Date

2021-03-22

Fiscal Year

2021

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2021
Citations: No

2019
06 Dec
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2019-12-06

FMD Date

2021-06-14

Fiscal Year

2020

State

Sodertalje, Sweden

Additional Details

Mutual Recognition Agreement (MRA)

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2020
Citations: No

2019
11 Oct
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2019-10-11

FMD Date

2020-07-21

Fiscal Year

2020

State

Sodertalje, Sweden

Additional Details

Mutual Recognition Agreement (MRA)

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2020
Citations: No

2019
30 Aug
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2019-08-30

FMD Date

2019-10-16

Fiscal Year

2019

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2019
Citations: No

2018
11 Oct
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2018-10-11

FMD Date

-

Fiscal Year

2019

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2019
Citations: No

2018
17 Aug
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2018-08-17

FMD Date

2018-11-05

Fiscal Year

2018

State

Maryland

Frederick, United States

Location

Frederick, Maryland, United States

Inspection Info

Fiscal Year: 2018
Citations: No

2018
20 Jun
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2018-06-20

FMD Date

2019-04-05

Fiscal Year

2018

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2018
Citations: No

2018
05 Feb
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2018-02-05

FMD Date

-

Fiscal Year

2018

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2018
Citations: No

2018
30 Jan
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2018-01-30

FMD Date

2019-03-25

Fiscal Year

2018

State

Maryland

Gaithersburg, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2018
Citations: Yes

2017
07 Dec
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2017-12-07

FMD Date

2020-01-22

Fiscal Year

2018

State

Sodertalje, Sweden

Additional Details

Mutual Recognition Agreement (MRA)

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2018
Citations: No

2017
18 May
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2017-05-18

FMD Date

2018-07-12

Fiscal Year

2017

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2017
Citations: No

2017
07 Feb
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2017-02-07

FMD Date

2017-05-15

Fiscal Year

2017

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2017
Citations: Yes

2017
27 Jan
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2017-01-27

FMD Date

2017-05-24

Fiscal Year

2017

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2017
Citations: No

2016
09 Dec
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-12-09

FMD Date

2018-07-12

Fiscal Year

2017

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2017
Citations: No

2016
27 Apr
Voluntary Action Indicated VAI

Legal Name

AstraZeneca LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2016-04-27

FMD Date

-

Fiscal Year

2016

State

Massachusetts

Westborough, United States

Location

Westborough, Massachusetts, United States

Inspection Info

Fiscal Year: 2016
Citations: Yes

2016
10 Mar
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-03-10

FMD Date

-

Fiscal Year

2016

State

Colorado

Denver, United States

Location

Denver, Colorado, United States

Inspection Info

Fiscal Year: 2016
Citations: No

2016
26 Feb
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-02-26

FMD Date

-

Fiscal Year

2016

State

California

Redwood City, United States

Location

Redwood City, California, United States

Inspection Info

Fiscal Year: 2016
Citations: No

2016
28 Jan
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-01-28

FMD Date

-

Fiscal Year

2016

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2016
Citations: No

2015
29 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-09-29

FMD Date

-

Fiscal Year

2015

State

Maryland

Gaithersburg, United States

Additional Details

Sponsor, Contract Research Organization

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2015
24 Jul
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-07-24

FMD Date

-

Fiscal Year

2015

State

Maryland

Frederick, United States

Location

Frederick, Maryland, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2015
19 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-06-19

FMD Date

-

Fiscal Year

2015

State

Delaware

Wilmington, United States

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2015
19 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-06-19

FMD Date

-

Fiscal Year

2015

State

Delaware

Wilmington, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2015
19 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-06-19

FMD Date

-

Fiscal Year

2015

State

Delaware

Wilmington, United States

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2015
20 May
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2015-05-20

FMD Date

-

Fiscal Year

2015

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2014
26 Sep
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-09-26

FMD Date

2015-03-24

Fiscal Year

2014

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2014
Citations: No

2014
26 Aug
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-08-26

FMD Date

-

Fiscal Year

2014

State

Delaware

Wilmington, United States

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2014
Citations: No

2014
23 Jul
No Action Indicated NAI

Legal Name

AstraZeneca LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-07-23

FMD Date

-

Fiscal Year

2014

State

Massachusetts

Westborough, United States

Location

Westborough, Massachusetts, United States

Inspection Info

Fiscal Year: 2014
Citations: No

2014
07 Apr
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-04-07

FMD Date

-

Fiscal Year

2014

State

Delaware

Wilmington, United States

Additional Details

Sponsor, Contract Research Organization

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2014
Citations: No

2014
28 Mar
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-03-28

FMD Date

2014-06-19

Fiscal Year

2014

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2014
Citations: No

2013
25 Oct
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2013-10-25

FMD Date

-

Fiscal Year

2014

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2014
Citations: No

2013
22 May
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2013-05-22

FMD Date

-

Fiscal Year

2013

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2013
12 Apr
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2013-04-12

FMD Date

-

Fiscal Year

2013

State

Delaware

Wilmington, United States

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2013
20 Mar
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2013-03-20

FMD Date

-

Fiscal Year

2013

State

Maryland

Gaithersburg, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2013
Citations: Yes

2012
27 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-09-27

FMD Date

-

Fiscal Year

2012

State

Delaware

Wilmington, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2012
Citations: No

2012
21 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-09-21

FMD Date

-

Fiscal Year

2012

State

Maryland

Frederick, United States

Location

Frederick, Maryland, United States

Inspection Info

Fiscal Year: 2012
Citations: No

2012
13 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-09-13

FMD Date

-

Fiscal Year

2012

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2012
Citations: No

2012
18 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-06-18

FMD Date

-

Fiscal Year

2012

State

Delaware

Wilmington, United States

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2012
Citations: No

2012
14 Jun
No Action Indicated NAI

Legal Name

AstraZeneca LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-06-14

FMD Date

-

Fiscal Year

2012

State

Massachusetts

Westborough, United States

Location

Westborough, Massachusetts, United States

Inspection Info

Fiscal Year: 2012
Citations: No

2012
07 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-06-07

FMD Date

-

Fiscal Year

2012

State

Delaware

Wilmington, United States

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2012
Citations: No

2012
29 May
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-05-29

FMD Date

2013-02-04

Fiscal Year

2012

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2012
Citations: No

2012
29 May
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-05-29

FMD Date

2013-02-04

Fiscal Year

2012

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2012
Citations: No

2011
28 Oct
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2011-10-28

FMD Date

-

Fiscal Year

2012

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2012
Citations: Yes

2011
12 Aug
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2011-08-12

FMD Date

-

Fiscal Year

2011

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2011
Citations: No

2011
03 May
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2011-05-03

FMD Date

-

Fiscal Year

2011

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2011
Citations: No

2011
27 Apr
Voluntary Action Indicated VAI

Legal Name

AstraZeneca LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2011-04-27

FMD Date

-

Fiscal Year

2011

State

Massachusetts

Westborough, United States

Location

Westborough, Massachusetts, United States

Inspection Info

Fiscal Year: 2011
Citations: Yes

2010
10 Dec
Voluntary Action Indicated VAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-12-10

FMD Date

2011-07-14

Fiscal Year

2011

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2011
Citations: No

2010
09 Dec
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-12-09

FMD Date

2011-07-20

Fiscal Year

2011

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2011
Citations: No

2010
10 Nov
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-11-10

FMD Date

-

Fiscal Year

2011

State

Delaware

Wilmington, United States

Additional Details

Sponsor, Contract Research Organization

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2011
Citations: No

2010
23 Jun
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2010-06-23

FMD Date

-

Fiscal Year

2010

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2010
Citations: Yes

2010
17 May
Voluntary Action Indicated VAI

Legal Name

AstraZeneca LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2010-05-17

FMD Date

-

Fiscal Year

2010

State

Massachusetts

Westborough, United States

Location

Westborough, Massachusetts, United States

Inspection Info

Fiscal Year: 2010
Citations: Yes

2010
31 Mar
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-03-31

FMD Date

-

Fiscal Year

2010

State

Delaware

Wilmington, United States

Additional Details

Sponsor, Contract Research Organization

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2010
Citations: No

2010
25 Mar
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-03-25

FMD Date

2010-08-13

Fiscal Year

2010

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2010
Citations: No

2010
19 Mar
No Action Indicated NAI

Legal Name

AstraZeneca AB

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-03-19

FMD Date

2010-08-13

Fiscal Year

2010

State

Sodertalje, Sweden

Location

Sodertalje, , Sweden

Inspection Info

Fiscal Year: 2010
Citations: No

2010
03 Feb
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-02-03

FMD Date

-

Fiscal Year

2010

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2010
Citations: No

2009
07 Dec
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2009-12-07

FMD Date

-

Fiscal Year

2010

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2010
Citations: Yes

2009
17 Sep
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-09-17

FMD Date

-

Fiscal Year

2009

State

Delaware

Wilmington, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Wilmington, Delaware, United States

Inspection Info

Fiscal Year: 2009
Citations: No

2009
18 Jun
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-06-18

FMD Date

-

Fiscal Year

2009

State

Maryland

Frederick, United States

Location

Frederick, Maryland, United States

Inspection Info

Fiscal Year: 2009
Citations: No

2009
16 Jun
Voluntary Action Indicated VAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2009-06-16

FMD Date

-

Fiscal Year

2009

State

Pennsylvania

Philadelphia, United States

Location

Philadelphia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2009
Citations: Yes

2009
29 Jan
No Action Indicated NAI

Legal Name

AstraZeneca Pharmaceuticals LP

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-01-29

FMD Date

-

Fiscal Year

2009

State

Indiana

Mount Vernon, United States

Location

Mount Vernon, Indiana, United States

Inspection Info

Fiscal Year: 2009
Citations: No

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Location

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Inspection Info

Fiscal Year: 2026
Citations: No

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