Mylan Laboratories Ltd., Speciality Formulation Facility - March 2, 2018
Issue Date
Mar 02, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Mohan Babu
Contact Title
Head, Complex-2 Manufacturing
Address 1
19a, Plot 284 - B/1 Jigani Link Road
City
Bangalore, Karnataka
Zip/Postal Code
560105
Country
India
Inspection Range
Feb 22, 2018 - Mar 02, 2018
Pages
4
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of inprocess material and the drug product.
Investigator(s): Yasamin Ameri