F. Hoffman - La Roche, Ltd. - Dec. 9, 2014
Issue Date
Dec 09, 2014
Region
HQ
Category
Drug
$117.00
Contact Name
Rainer Schmidt
Contact Title
Site Head, Drug Product Manufacturing Operations
Address 1
Warmisweg
Address 2
Ch-4303 Kaiseraugst
Country
Switzerland
Inspection Range
Dec 01, 2014 - Dec 09, 2014
Pages
1
First Observation
The Drug Product manufacturing process is not adequately validated.
Investigator(s): Laura Fontan and Zhihao Peter Qiu