Regulatory inspections
We regularly participate in regulatory inspections to help ensure the highest quality in our operations in development, manufacturing and distribution. A total of 187 inspections were completed in 2019 by external health authorities (e.g., FDA, EMA), and all but six were deemed acceptable (96.8%). The six inspections that required further improvement were due to new acquisitions and increased inspection focus on our clinical activities. In each of these cases, corrective and preventative actions (accepted by the health authorities) were taken to improve our systems in product quality, patient safety, clinical trial monitoring and manufacturing compliance.
|
All regulatory authorities |
2015 |
2016 |
2017 |
2018 |
2019 |
|---|---|---|---|---|---|
|
Inspections |
192 |
206 |
217 |
202 |
187 |
|
% without major findings |
98.4 |
98.1 |
99.1 |
98.5 |
96.8 |
|
FDA inspections |
31 |
26 |
30 |
18 |
19 |
|
FDA warning letters |
1 |
0 |
0 |
0 |
0 |
|
FDA Form 483 |
10 |
14 |
14 |
8 |
11 |
|
FDA sponsor inspections1 |
2015 |
2016 |
2017 |
2018 |
2019 |
|---|---|---|---|---|---|
|
Inspections related to clinical trial management and pharmacovigilance |
4 |
5 |
5 |
2 |
2 |
|
Number of VAI (Voluntary Action Indicated) |
0 |
1 |
2 |
0 |
1 |
|
Number of OAI (Official Action Indicated) |
0 |
0 |
0 |
0 |
0 |
[1] As recorded in the Inspection Classification Database on the FDA’s website