Biocon Sein. Bhd. - July 20, 2023
Issue Date
Jul 20, 2023
Region
HQ
Category
Drug
$117.00
Contact Name
Kiran Kumar Gandhirajan
Contact Title
Senior Vice President & Site Head
Address 1
No.1 Jalan Bioteknologi 1, Kawasan Perindustrian SiLC
City
79200 lskandar Puteri, Johor
Country
Malaysia
Inspection Range
Jul 10, 2023 - Jul 20, 2023
Pages
10
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, or followed.
Investigator(s): Rong Guo, Patty Kaewussdangkul, Daniel J. Lahar, and Eileen A. Liu