We regularly participate in regulatory inspections to help ensure the highest quality in our operations in development, manufacturing and distribution.  

In 2022, health authorities, including the European Medicines Agency (EMA), Swissmedic and the US Food and Drug Administration (FDA), carried out a total of 139 inspections. Of these, 100% were found to be acceptable, up from 99.2% in 2021.

Regulatory authorities

2017

2018

2019

2020

2021 2022

Total inspections

217

202

187

126

126 139

Inspections found to be acceptable (%)

99.1

98.5

96.8

99.2

99.2 100
US FDA  

FDA inspections

30

18

19

6

10 10

FDA warning letters

0

0

0

0

0 0

FDA Form 483

14

8

11

1

5 7

 

US FDA sponsor inspections

2017

2018

2019

2020

2021 2022

Inspections related to clinical trial management and pharmacovigilance

5

3

2

1

3 1

Number of FDA VAI (Voluntary Action Indicated) classifications

2

1

1

0

0 0

Number of FDA OAI (Official Action Indicated) classifications

0

0

0

0

0 0