Eisai Co., Ltd. Kashima Plant - Nov. 18, 2022
Issue Date
Nov 18, 2022
Region
HQ
Category
Drug
$117.00
Contact Name
Makoto Uemura
Contact Title
General Manager
Address 1
C. 22 Sunayama, Kamisu-shi
City
Ibaraki
Zip/Postal Code
314-0255
Country
Japan
Inspection Range
Nov 14, 2022 - Nov 18, 2022
Pages
2
First Observation
Appropriate controls are not exercised over computers or related systems to assure that changes are instituted only
by authorized personnel in the following systems used in the testing of raw materials, intermediates and active pharmaceutical ingredients (API).
Investigator(s): Rumany C. Penn