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），软盘管理，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 |