H2O Plus, L.P. - September 20, 2010
Issue Date
Sep 30, 2010
Region
Central
Category
Drug
$117.00
Address 1
845 W. Madison St.
City
Chicago
State
IL
Zip/Postal Code
60607
Country
US
Inspection Range
Sep 21, 2010 - Sep 30, 2010
Pages
5
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): Debra I. Love