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。
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 |
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 |
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 |