Takeda Pharmaceutical Co. Ltd. - Aug. 9, 2019
Issue Date
Aug 09, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Naoki Asakawa
Contact Title
Vice President and Head of Osaka Plant
Address 1
2 Chome 17-85, Jusohon-Machi, Yodogawa
City
Osaka
Zip/Postal Code
532-0024
Country
Japan
Inspection Range
Aug 01, 2019 - Aug 09, 2019
Pages
5
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Investigator(s): Patric C. Klotzbuecher and Gam S. Zamil