Kyowa Hakko Kirin Co., Ltd., Sakai Plant - Jan. 16, 2015
Issue Date
Jan 16, 2015
Region
HQ
Category
Drug
$117.00
Contact Name
Shin-ichiro Mohri
Contact Title
Plant Manager
Address 1
1-1-53, Takasu-cho
City
Sakai-ku, Sakashi
State
Osaka
Zip/Postal Code
590-8554
Country
Japan
Inspection Range
Jan 13, 2015 - Jan 16, 2015
Pages
1
First Observation
There is inadequate control over the use of "preconditioning" injections during HPLC analyses in the QC laboratory.
Investigator(s): Jeffrey D. Meng