Aurobindo Pharma, Ltd. - Unit IV - Dec. 14, 2018
Issue Date
Dec 14, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Rajesh Kulkarni
Contact Title
Vice President Quality
Address 1
Plot Nos. 4, 34 to 48, Epip, Tsiic, Ida
Address 2
Pashamylaram, Patancheru Mandal, Sangareddy
City
Medak District, Hyderabad
State
Telangana
Zip/Postal Code
502307
Country
India
Inspection Range
Dec 03, 2018 - Dec 14, 2018
Pages
12
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Investigator(s): Jose A. Cruz-Gonzalez