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

In2022,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 from99.2%in2021。

调节自动装置

2017

2018

2019

2020

2021 2022

总指数

217

202

187

126

126 139

检查found to be acceptable(%)

99.1

98.5

96.8

99.2

99.2 100
美国FDA

FDA检测

30

18

19

6个

10 10

FDA warning letters

0

0

0

0

0 0

FDA Form483

14

8个

11

1个

5 7

 

美国FDA sponsor inspections

2017

2018

2019

2020

2021 2022

检验到clinical trial management and pharmacovigilance

5

3

2

1个

3 1个

Voluntary Action Indicated classifications

2

1个

1个

0

0 0

FDA OAI(Official Action Indicated)classifications

0

0

0

0

0 0