Horizon Pharmaceuticals, Inc. - September 26, 2011
Issue Date
Sep 26, 2011
Region
Southeast
Category
Drug
$117.00
Address 1
971 W. 15th St.
City
West Palm Beach
State
FL
Zip/Postal Code
33404-6719
Country
US
Inspection Range
Sep 19, 2011 - Sep 26, 2011
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): Noreen Muniz