AstraZeneca - NAI
FDA Inspections Database

AstraZeneca - NAI

FDA Inspections Database

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

NAI · No Action Indicated United States
  • Total Records 46
  • Latest Inspection 2026-01-14
  • Data Source U.S. FDA
  • Last Updated 2026-04-02

77

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46

NAI
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31

VAI
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Company Overview

Company

AstraZeneca - NAI

Country

United Kingdom

Social Profiles

LinkedIn X / Twitter
Company Snapshot

AstraZeneca - NAI

2 Kingdom Street, Paddington, London W2 6BD

United Kingdom

www.astrazeneca.com/ Russell.Gantt@astrazeneca.com View on Map
FDA Inspections Timeline (46 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
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
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

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

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
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

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
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
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
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

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
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

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

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

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
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

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
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
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
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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Classification Breakdown
46 total
  • NAI (No Action Indicated)
Official Source

All data is sourced from the official FDA inspection database maintained by the U.S. Food and Drug Administration.

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Location

Gaithersburg, Maryland, United States

Inspection Info

Fiscal Year: 2026
Citations: No

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