Celltrion, Inc. - July 17, 2018
Issue Date
Jul 17, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Woo Sung Kee
Contact Title
Vice Chairman/CEO
Address 1
23 Academy-Ro
Address 2
Yeonsu-Gu
City
Incheon City
Zip/Postal Code
406-840
Country
Korea
Inspection Range
Jul 09, 2018 - Jul 17, 2018
Pages
4
First Observation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Investigator(s): Jacek Cieslak, Richard Ledwidge, and Ashar P. Parikh