Sandoz, GmbH - Dec. 17, 2021
Issue Date
Dec 17, 2021
Region
HQ
Category
Drug
$117.00
Contact Name
Stefan Steger
Contact Title
Site Head Drug Substance Kundl
Address 1
Biochemiestrasse 10
City
Kundl
Zip/Postal Code
6250
Country
Austria
Inspection Range
Dec 09, 2021 - Dec 17, 2021
Pages
2
First Observation
On 14th December 2021, I observed the … drug substance filled into … liter sterile … bottles, with each bottle not inspected prior to the fill process for defects that should include absence of debris within the bottle.
Investigator(s): Xianghong Jing and Wayne Seifert