Kyongbo Pharmaceutical Co., Ltd. - Dec. 1, 2017
Issue Date
Dec 01, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Hoe-Ju Son
Contact Title
Plant Director
Address 1
174 Sirok-ro
City
Asan-si, Chuncheongnam-do
Zip/Postal Code
31501
Country
Korea
Inspection Range
Nov 27, 2017 - Dec 01, 2017
Pages
3
First Observation
Your firm failed to evaluate during process validation activities the operational speed range ... used in the ... of the raw materials during the manufacture of your finished APls.
Investigator(s): Jose E. Melendez