Otsuka Pharmaceutical Co., Ltd. - July 22, 2016
Issue Date
Jul 22, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Motoyuki Yamanishi
Contact Title
Plant Manager
Address 1
Matsutani, Itano- cho, Tokushima Itano Factory
Address 2
Itanogun
City
Tokushima
Zip/Postal Code
7790195
Country
Japan
Inspection Range
Jul 18, 2016 - Jul 22, 2016
Pages
5
First Observation
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Investigator(s): Cheryl Clausen