Sun Pharmaceuticals Industries, Inc. - April 28, 2010
Issue Date
Apr 28, 2010
Region
Central
Category
Drug
$117.00
Address 1
270 Prospect Plains Rd.
City
Cranbury
State
NJ
Zip/Postal Code
8512
Country
US
Inspection Range
Feb 25, 2010 - Apr 28, 2010
Pages
6
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 of the in-process material and drug product.
Investigator(s): Karen D'Orazio, Luis A. Dasta, Justine C. Tomasso, and Lauren L. Vajo