Novartis Pharmaceuticals Corporation - VAI
FDA Inspections Database

Novartis Pharmaceuticals Corporation - VAI

FDA Inspections Database

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

VAI · Voluntary Action Indicated Switzerland
  • Total Records 30
  • Latest Inspection 2025-03-27
  • Data Source U.S. FDA
  • Last Updated -

74

All
View

44

NAI
View

30

VAI
View
Company Overview

Company

Novartis Pharmaceuticals Corporation - VAI

Country

Switzerland

Email

Social Profiles

Company Snapshot

Novartis Pharmaceuticals Corporation - VAI

Klybeckstrasse 141, CH-4057, Basel

Switzerland

www.novartis.com/ View on Map
FDA Inspections Timeline (30 records)
2025
27 Mar
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Schweizerhalle Ag

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2025-03-27

FMD Date

-

Fiscal Year

2025

State

Pratteln, Switzerland

Additional Details

Mutual Recognition Agreement (MRA)

Location

Pratteln, , Switzerland

Inspection Info

Fiscal Year: 2025
Citations: No

2024
08 Aug
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Human Cellular, Tissue, and Gene Therapies

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2024-08-08

FMD Date

2025-07-07

Fiscal Year

2024

State

New Jersey

Morris Plains, United States

Location

Morris Plains, New Jersey, United States

Inspection Info

Fiscal Year: 2024
Citations: Yes

2023
21 Aug
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2023-08-21

FMD Date

2023-10-30

Fiscal Year

2023

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2023
Citations: Yes

2022
09 Dec
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Human Cellular, Tissue, and Gene Therapies

Product Type

Biologics

Posted Citations

No

Inspection End Date

2022-12-09

FMD Date

2024-02-27

Fiscal Year

2023

State

New Jersey

Morris Plains, United States

Location

Morris Plains, New Jersey, United States

Inspection Info

Fiscal Year: 2023
Citations: No

2022
06 Dec
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Stein AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2022-12-06

FMD Date

2023-01-24

Fiscal Year

2023

State

Stein Ag, Switzerland

Location

Stein Ag, , Switzerland

Inspection Info

Fiscal Year: 2023
Citations: No

2022
30 Aug
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2022-08-30

FMD Date

2022-11-07

Fiscal Year

2022

State

Basel, Switzerland

Location

Basel, , Switzerland

Inspection Info

Fiscal Year: 2022
Citations: No

2019
21 Aug
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Human Cellular, Tissue, and Gene Therapies

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2019-08-21

FMD Date

2020-02-14

Fiscal Year

2019

State

New Jersey

Morris Plains, United States

Location

Morris Plains, New Jersey, United States

Inspection Info

Fiscal Year: 2019
Citations: Yes

2019
02 Jul
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2019-07-02

FMD Date

2020-05-15

Fiscal Year

2019

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2019
Citations: Yes

2018
14 Dec
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2018-12-14

FMD Date

2023-10-16

Fiscal Year

2019

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2019
Citations: Yes

2018
04 Dec
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Stein AG

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

Yes

Inspection End Date

2018-12-04

FMD Date

2019-06-28

Fiscal Year

2019

State

Stein Ag, Switzerland

Location

Stein Ag, , Switzerland

Inspection Info

Fiscal Year: 2019
Citations: Yes

2017
06 Jul
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2017-07-06

FMD Date

-

Fiscal Year

2017

State

Basel, Switzerland

Location

Basel, , Switzerland

Inspection Info

Fiscal Year: 2017
Citations: No

2017
23 Jun
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Schweizerhalle Ag

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2017-06-23

FMD Date

2017-07-20

Fiscal Year

2017

State

Pratteln, Switzerland

Location

Pratteln, , Switzerland

Inspection Info

Fiscal Year: 2017
Citations: No

2017
09 May
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Stein AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2017-05-09

FMD Date

2017-08-07

Fiscal Year

2017

State

Stein Ag, Switzerland

Location

Stein Ag, , Switzerland

Inspection Info

Fiscal Year: 2017
Citations: Yes

2017
24 Jan
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2017-01-24

FMD Date

-

Fiscal Year

2017

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2017
Citations: Yes

2015
16 Oct
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Stein AG

Project Area

Vaccines and Allergenic Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2015-10-16

FMD Date

-

Fiscal Year

2016

State

Stein Ag, Switzerland

Location

Stein Ag, , Switzerland

Inspection Info

Fiscal Year: 2016
Citations: No

2014
05 Aug
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2014-08-05

FMD Date

-

Fiscal Year

2014

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2014
Citations: Yes

2014
28 Feb
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2014-02-28

FMD Date

-

Fiscal Year

2014

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2014
Citations: Yes

2012
02 Nov
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-11-02

FMD Date

-

Fiscal Year

2013

State

California

Vacaville, United States

Location

Vacaville, California, United States

Inspection Info

Fiscal Year: 2013
Citations: No

2012
26 Jul
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-07-26

FMD Date

2012-12-11

Fiscal Year

2012

State

Basel, Switzerland

Location

Basel, , Switzerland

Inspection Info

Fiscal Year: 2012
Citations: No

2012
22 Jun
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Stein AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-06-22

FMD Date

2013-01-16

Fiscal Year

2012

State

Stein Ag, Switzerland

Location

Stein Ag, , Switzerland

Inspection Info

Fiscal Year: 2012
Citations: No

2012
08 Jun
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma AG

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2012-06-08

FMD Date

-

Fiscal Year

2012

State

Basel, Switzerland

Additional Details

Sponsor, Contract Research Organization

Location

Basel, , Switzerland

Inspection Info

Fiscal Year: 2012
Citations: No

2011
12 May
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Blood and Blood Products

Product Type

Biologics

Posted Citations

No

Inspection End Date

2011-05-12

FMD Date

-

Fiscal Year

2011

State

California

Vacaville, United States

Location

Vacaville, California, United States

Inspection Info

Fiscal Year: 2011
Citations: No

2011
25 Feb
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2011-02-25

FMD Date

-

Fiscal Year

2011

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2011
Citations: Yes

2010
09 Jul
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Schweizerhalle Ag

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-07-09

FMD Date

2010-11-09

Fiscal Year

2010

State

Pratteln, Switzerland

Location

Pratteln, , Switzerland

Inspection Info

Fiscal Year: 2010
Citations: No

2010
02 Jul
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma Stein AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2010-07-02

FMD Date

2010-09-16

Fiscal Year

2010

State

Stein Ag, Switzerland

Location

Stein Ag, , Switzerland

Inspection Info

Fiscal Year: 2010
Citations: No

2009
24 Apr
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2009-04-24

FMD Date

-

Fiscal Year

2009

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2009
Citations: Yes

2009
05 Feb
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2009-02-05

FMD Date

-

Fiscal Year

2009

State

California

Vacaville, United States

Location

Vacaville, California, United States

Inspection Info

Fiscal Year: 2009
Citations: Yes

2008
21 Nov
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma AG

Project Area

Drug Quality Assurance

Product Type

Drugs

Posted Citations

No

Inspection End Date

2008-11-21

FMD Date

2009-02-23

Fiscal Year

2009

State

Basel, Switzerland

Location

Basel, , Switzerland

Inspection Info

Fiscal Year: 2009
Citations: No

2008
18 Nov
Voluntary Action Indicated VAI

Legal Name

Novartis Pharmaceuticals Corporation

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

Yes

Inspection End Date

2008-11-18

FMD Date

-

Fiscal Year

2009

State

New Jersey

East Hanover, United States

Additional Details

Sponsor, Contract Research Organization

Location

East Hanover, New Jersey, United States

Inspection Info

Fiscal Year: 2009
Citations: Yes

2008
06 Nov
Voluntary Action Indicated VAI

Legal Name

Novartis Pharma AG

Project Area

Bioresearch Monitoring

Product Type

Drugs

Posted Citations

No

Inspection End Date

2008-11-06

FMD Date

-

Fiscal Year

2009

State

Basel, Switzerland

Additional Details

Sponsor, Contract Research Organization

Location

Basel, , Switzerland

Inspection Info

Fiscal Year: 2009
Citations: No

Related Databases
  • FDA Inspections
    74 View
  • EDQM CEP
    3 View
  • KDMF
    0 View
  • Japan DMF
    2 View
  • Eudra GMP
    0 View
Classification Breakdown
30 total
  • 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

Pratteln, , Switzerland

Inspection Info

Fiscal Year: 2025
Citations: No

100% Official Data

Directly from the U.S. FDA inspection database

Regular Updates

Data updated regularly from official sources

Trusted by Professionals

100K+ pharma professionals worldwide

Secure & Reliable

Enterprise-grade security and data protection

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

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.