Ingenus Pharmaceuticals GmbH - Dec. 11, 2018
Issue Date
Dec 11, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Bogdan Mihai Oghina
Contact Title
Site Director
Address 1
Via Cadepiano 24
City
Barbengo
State
Ticino
Zip/Postal Code
6917
Country
Switzerland
Inspection Range
Dec 03, 2018 - Dec 11, 2018
Pages
4
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Yasamin Ameri