Samsung Biologics Corp., Ltd. - May 11, 2018
Issue Date
May 11, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Tae Han Kim
Contact Title
President and CEO
Address 1
300, Songdo Bio-Daero
City
Yeonsu-Gu, Incheon
Zip/Postal Code
21987
Country
Republic of Korea
Inspection Range
May 07, 2018 - May 11, 2018
Pages
4
First Observation
Procedures to prevent microbial contamination of drug products purporting to be sterile are not followed.
Investigator(s): Virginia Carroll, Diane L. Raccasi, and Michael R. Shanks