Inopak, Ltd. - August 21, 2009
Issue Date
Aug 21, 2009
Region
Central
Category
Drug
$117.00
Address 1
24 Executive Pkwy
City
Ringwood
State
NJ
Zip/Postal Code
7456
Country
US
Inspection Range
Aug 19, 2009 - Aug 21, 2009
Pages
1
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): Michael R. Klopal