We regularly participate in regulatory inspections to help ensure the highest quality in our operations in development, manufacturing and distribution.
Of 126 inspections of our facilities by health authorities around the world in 2021, all but one were found to be acceptable without major findings. A corrective action plan was submitted for the one inspection that required further improvement and the plan was deemed acceptable by the health authority (EMA). Of the 126 inspections, 31 were performed remotely, and one FDA inspection relied on a prior inspection conducted by the Austrian healthcare authorities under a mutual recognition agreement.
|
All regulatory authorities |
2017 |
2018 |
2019 |
2020 |
2021 |
|---|---|---|---|---|---|
|
Inspections |
217 |
202 |
187 |
126 |
126 |
|
% Inspections considered acceptable |
99.1 |
98.5 |
96.8 |
99.2 |
99.2% |
|
FDA inspections |
30 |
18 |
19 |
6 |
10 |
|
FDA warning letters |
0 |
0 |
0 |
0 |
0 |
|
FDA Form 483 |
14 |
8 |
11 |
1 |
5 |
|
FDA sponsor inspections |
2017 |
2018 |
2019 |
2020 |
2021 |
|---|---|---|---|---|---|
|
Inspections related to clinical trial management and pharmacovigilance |
5 |
3 |
2 |
1 |
3 |
|
Number of VAI (Voluntary Action Indicated) |
2 |
1 |
1 |
0 |
0 |
|
Number of OAI (Official Action Indicated) |
0 |
0 |
0 |
0 |
0 |