Hisamitsu Pharmaceutical Co., Inc. - Oct. 11, 2019
Issue Date
Oct 11, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Toshiaki Tsuruda
Contact Title
Director, Executive Officer, Head of Production Division
Address 1
Kiyohara 23-8, Kiyoharakogyodanchi
City
Utsunomiya
State
Tochigi
Zip/Postal Code
321-3231
Country
Japan
Inspection Range
Oct 07, 2019 - Oct 11, 2019
Pages
9
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