Otsuka Pharmaceutical Co., Ltd. - April 8, 2016
Issue Date
Apr 08, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Toshikazu Ochi
Contact Title
Plant Manager of Saga Factory
Address 1
5006-5 Aza Higashiyama
Address 2
Omagari
City
Yoshioogan-cho
Zip/Postal Code
8420197
Country
Japan
Inspection Range
Apr 04, 2016 - Apr 08, 2016
Pages
5
First Observation
Your firm failed to establish clean hold times for all non-dedicated manufacturing equipment, including equipment utlized for manufacture of APIs destined for the US market.
Investigator(s): Saleem A. Akhtar