Fukuzyu Pharmaceutical Co., Ltd. - July 28, 2016
Issue Date
Jul 28, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Takayoshi Fujimaki
Contact Title
Plant Manager
Address 1
48 Hagiwara
City
Toyama
Zip/Postal Code
9398261
Country
Japan
Inspection Range
Jul 25, 2016 - Jul 28, 2016
Pages
1
First Observation
The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of an active pharmaceutical ingredient.
Investigator(s): Reba A. Gates and Lillie D. Witcher