GSK
FDA Inspections Database

GSK

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 24
  • Latest Inspection 2026-02-20
  • Data Source U.S. FDA
  • Last Updated 2026-04-02

24

All
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20

NAI
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4

VAI
View
Company Overview

Company

GSK

Country

United Kingdom

Website

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Company Snapshot

GSK

980 Great West Road, Brentford, Middlesex TW8 9GS England

United Kingdom

www.gsk.com:443/en-gb/ View on Map
FDA Inspections Timeline (24 records)
2026
20 Feb
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2026-02-20

FMD Date

2026-04-02

Fiscal Year

2026

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2026
Citations: No

2024
16 Aug
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2024-08-16

FMD Date

2024-12-19

Fiscal Year

2024

State

North Carolina

Durham, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2024
Citations: No

2024
19 Apr
Voluntary Action Indicated VAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2024-04-19

FMD Date

2024-06-10

Fiscal Year

2024

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2024
Citations: Yes

2019
12 Sep
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2019-09-12

FMD Date

2020-03-18

Fiscal Year

2019

State

North Carolina

Durham, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2019
Citations: No

2018
26 Jan
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2018-01-26

FMD Date

2018-03-07

Fiscal Year

2018

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2018
Citations: No

2016
15 Jul
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-07-15

FMD Date

2016-11-29

Fiscal Year

2016

State

North Carolina

Durham, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2016
Citations: No

2016
15 Jul
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2016-07-15

FMD Date

2016-11-29

Fiscal Year

2016

State

North Carolina

Durham, United States

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2016
Citations: No

2016
21 Apr
Voluntary Action Indicated VAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2016-04-21

FMD Date

-

Fiscal Year

2016

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2016
Citations: Yes

2015
21 Aug
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-08-21

FMD Date

-

Fiscal Year

2015

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2015
10 Apr
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2015-04-10

FMD Date

-

Fiscal Year

2015

State

North Carolina

Durham, United States

Additional Details

Sponsor, Contract Research Organization

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2015
Citations: No

2014
29 Sep
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2014-09-29

FMD Date

-

Fiscal Year

2014

State

North Carolina

Durham, United States

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2014
Citations: No

2013
23 Aug
Voluntary Action Indicated VAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2013-08-23

FMD Date

-

Fiscal Year

2013

State

Pennsylvania

King of Prussia, United States

Additional Details

Sponsor, Contract Research Organization

Location

King of Prussia, Pennsylvania, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2013
03 May
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2013-05-03

FMD Date

-

Fiscal Year

2013

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2013
05 Feb
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2013-02-05

FMD Date

-

Fiscal Year

2013

State

North Carolina

Durham, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2013
31 Jan
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2013-01-31

FMD Date

-

Fiscal Year

2013

State

North Carolina

Durham, United States

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2012
19 Dec
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-12-19

FMD Date

-

Fiscal Year

2013

State

North Carolina

Durham, United States

Additional Details

Sponsor, Contract Research Organization

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2010
27 Jul
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-07-27

FMD Date

-

Fiscal Year

2010

State

North Carolina

Durham, United States

Additional Details

Sponsor, Contract Research Organization

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2010
Citations: No

2010
14 May
Voluntary Action Indicated VAI

Legal Name

Glaxosmithkline

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-05-14

FMD Date

-

Fiscal Year

2010

State

Uxbridge, United Kingdom

Additional Details

Sponsor, Contract Research Organization

Location

Uxbridge, , United Kingdom

Inspection Info

Fiscal Year: 2010
Citations: No

2010
19 Feb
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-02-19

FMD Date

-

Fiscal Year

2010

State

North Carolina

Durham, United States

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2010
Citations: No

2009
20 Nov
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-11-20

FMD Date

-

Fiscal Year

2010

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2010
Citations: No

2009
24 Aug
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-08-24

FMD Date

-

Fiscal Year

2009

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2009
Citations: No

2009
24 Aug
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-08-24

FMD Date

-

Fiscal Year

2009

State

North Carolina

Zebulon, United States

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2009
Citations: No

2009
12 Jun
No Action Indicated NAI

Legal Name

Glaxosmithkline

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-06-12

FMD Date

-

Fiscal Year

2009

State

Marly le Roi, France

Additional Details

Postmarket Adverse Drug Experience (PADE)

Location

Marly le Roi, , France

Inspection Info

Fiscal Year: 2009
Citations: No

2009
11 Jun
No Action Indicated NAI

Legal Name

GlaxoSmithKline LLC

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2009-06-11

FMD Date

-

Fiscal Year

2009

State

North Carolina

Durham, United States

Additional Details

Sponsor, Contract Research Organization

Location

Durham, North Carolina, United States

Inspection Info

Fiscal Year: 2009
Citations: No

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Classification Breakdown
24 total
  • NAI (No Action Indicated)
  • VAI (Voluntary Action Indicated)
Official Source

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

Visit FDA.gov
Record Details Preview

Click "View Details" on any record above to expand full details inline.

Location

Zebulon, North Carolina, United States

Inspection Info

Fiscal Year: 2026
Citations: No

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FDA inspection data is compiled from publicly available U.S. FDA inspection classification records.

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