We regularly participate in regulatory inspections to help ensure the highest quality in our operations in development, manufacturing and distribution.
Health authorities, including the European Medicines Agency (EMA), Swissmedic and the US Food and Drug Administration (FDA), carried out the following inspections in the last three years.
| Regulatory authorities | 2022 | 2023 | 2024 |
|---|---|---|---|
| Total inspections | 106 | 113 | 124 |
| Inspections found to be acceptable (%) | 100 | 99.1 | 100 |
US FDA | |||
| FDA inspections | 7 | 10 | 9 |
| FDA warning letters | 0 | 0 | 0 |
| FDA Form 483 | 5 | 5 | 4 |
| Inspections | 2022 | 2023 | 2024 |
|---|---|---|---|
| Inspections related to clinical trial management and pharmacovigilance | n/r | n/r | 21 |
| Number of FDA VAI (Voluntary Action Indicated) classifications | 0 | 1 | 0 |
| Number of FDA OAI (Official Action Indicated) classifications | 0 | 0 | 0 |