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 |