Roche Diagnostics, GmbH - July 14, 2023
Issue Date
Jul 14, 2023
Region
HQ
Category
Drug
$117.00
Contact Name
Andreas Rascher
Contact Title
Site Head Sterile Drug Product Manufacturing
Address 1
Sandhofer Strasse 116
City
Mannheim, Baden-Wiitttemberg
Zip/Postal Code
D-68305
Country
Germany
Inspection Range
Jul 10, 2023 - Jul 14, 2023
Pages
3
First Observation
Procedures designed to prevent microbiological contamination of Operation … drug product and Operation … drug product purporting to be sterile are not established and/or followed.
Investigator(s): Maria Gutierrez-Hoffmann and Michael R. Shanks