Regulatory inspections

We regularly participate in regulatory inspections to help ensure the highest quality in our operations in development, manufacturing and distribution. Health authority inspection programs were also impacted by the COVID-19 pandemic, with some inspections postponed or conducted remotely. Novartis was subject to 19 remote inspections, all of which had acceptable outcomes. Postponed inspections will be performed as soon as possible, based on a risk-benefit evaluation by the responsible health authority. A total of 126 inspections were completed in 2020 by external health authorities (e.g., FDA, EMA). All but one were found to be good or acceptable (99.2%). The one inspection that may require further improvement was due to increased inspection focus on our clinical activities. The final classification of this inspection by the health authority is still to be determined.

All regulatory authorities

2016

2017

2018

2019

2020

Inspections

206

217

202

187

126

% Inspections considered acceptable

98.1

99.1

98.5

96.8

99.2

FDA inspections

26

30

18

19

6

FDA warning letters

0

0

0

0

0

FDA Form 483

14

14

8

11

1

 

FDA sponsor inspections

2016

2017

2018

2019

2020

Inspections related to clinical trial management and pharmacovigilance

5

5

3

2

1

Number of VAI (Voluntary Action Indicated)

1

2

1

1

0

Number of OAI (Official Action Indicated)

0

0

0

0

0