Otsuka Pharmaceutical Co., Ltd. - Feb. 12, 2016
Issue Date
Feb 12, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Dr. Shinichi Taira
Contact Title
Plant Manager
Address 1
224-18 Hiraishi Ebisuno
City
Kawauchi-cho
Zip/Postal Code
7710182
Country
Japan
Inspection Range
Feb 01, 2016 - Feb 12, 2016
Pages
5
First Observation
The firm's study to demonstrate the () during the aseptic step in the manufacturing process of Sterile API was found inadequate to demonstrate such.
Investigator(s): Jose A. Cruz-Gonzalez and Adaliz Santaliz-Cruz