Apotex Research Private Ltd. - Nov. 17, 2017
Issue Date
Nov 17, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Rav Kumar
Contact Title
Managing Director
Address 1
Plot 1 & 2. Bommasandra Ind. Area, 4th Phase, Jigani Link Rd.
City
Bangalore
State
Karnataka
Zip/Postal Code
560099
Country
India
Inspection Range
Nov 06, 2017 - Nov 17, 2017
Pages
9
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Rebecca E. Dombrowski, Sandra A. Hughes, and Aditi S. Thakur