Otsuka Pharmaceutical Co., Ltd. - Oct. 22, 2019
Issue Date
Oct 22, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Takafumi Matsutani
Contact Title
Plant Manager
Address 1
Tokushima Wajiki Factory, Koniu, Naka-Cho
City
Naka-Gun, Tokushima
Zip/Postal Code
771-5209
Country
Japan
Inspection Range
Oct 15, 2019 - Oct 22, 2019
Pages
13
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Pratik S. Upadhyay