Amgen Singapore Manufacturing - Jan. 27, 2017
Issue Date
Jan 27, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Arleen Paulino
Contact Title
Vice President Site Operations
Address 1
1 Tuas View Dr.
Zip/Postal Code
637026
Country
Singapore
Inspection Range
Jan 16, 2017 - Jan 27, 2017
Pages
1
First Observation
There are numerous incidents of leaks of the [systems] used for drug substance manufacturing.
Investigator(s): Reyes Candau-Chacon, Bo Chi, Bazarragchaa Damdinsuren, Steven Fong, and Haoheng Yan