ST Pharm Co., Ltd. - July 14, 2023
Issue Date
Jul 14, 2023
Region
HQ
Category
Drug
$117.00
Contact Name
Dunki Chang
Contact Title
Head Chemical Development & Manufacturing, Senior Vice President
Address 1
171 Haean-ro, Danwong-gu
City
Ansan-si, Gyeonggi-do
Zip/Postal Code
15610
Country
South Korea
Inspection Range
Jul 10, 2023 - Jul 14, 2023
Pages
2
First Observation
Complete records of equipment used in manufacturing was not available for review and fail to have appropriate computer controls.
Investigator(s): Lata C. Mathew